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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02270 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ENT0066 | Other Identifier | OnCore Number | |
| P30CA124435 | U.S. NIH Grant/Contract | View source | |
| R01CA190306 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods [positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].
For patients with head and neck cancer, detection of malignant cells within nearby lymph nodes (LNs) is an important measure of the extent and severity of the cancer. LNs are a key immunologic organ involved in overall immune surveillance. Historically, LN or LNs were harvested before the surgery of curative intent, evaluated pathologically, and then tumor status of the harvested LNs were utilized to inform the individual surgical plan. These LNs became known as "sentinel lymph nodes." In recent years, techniques have been developed to utilize peritumoral injection (around the tumor) of tumor labels that could identify tumor in the LNs without biopsy, ie, only LNs that were tumor-positive would be removed. However, in some patients, this technique could be limited by the location of the primary cancer. Effective and sensitive systemically-administered labels would be a significant advancement. The systemically-administered label 18F-fluorodeoxyglucose (18F-FDG), detected by positron emission tomography / computed tomography (PET/CT) and/or PET / magnetic imaging resonance (PET/MRI) radiologic scans and representing current regular medical care, has provided improvement in detection of cancer-positive LNs. However, further enhancements may be possible.
Participants with squamous cell carcinoma of the head and neck (SCCHN) and scheduled to undergo regular medical care surgery with curative intent, were assigned to 2 study groups on the basis of whether regular medical care scans using 18F-FDG PET/CT or PET/MRI had indicated that cancer was suspected in the lymph nodes (LN+ or cN+), or without suspected cancer in the lymph nodes (LN- or cN0). Following the 18F-FDG, and prior to surgery, 89Zr-panitumumab was systemically administered by intravenous infusion, and a PET-CT imaging scan was conducted. Research imaging will be performed intraoperatively using optical imaging devices and a high-energy gamma probe. Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. Regular medical care surgical excision of the tumor and adjacent LN was conducted on Day 2 to 5. After surgery, patients are followed up at 15 and 30 days.
PRIMARY OBJECTIVES:
I. Determine the sensitivity and specificity of zirconium(89Zr)-panitumumab (89Zr-panitumumab) for the detection of tumor-involved regional lymph nodes.
SECONDARY OBJECTIVES:
I. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr-panitumumab labeling.
EXPLORATORY OBJECTIVES:
I. Determine the sensitivity and specificity of panitumumab-IRDye800 for the detection of tumor-involved regional lymph nodes.
II. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by panitumumab-IRDye800 labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor-negative Lymph Nodes (by 18F-FDG scan) | Experimental | Participants whose lymph nodes are negative for cancer |
|
| Tumor-positive Lymph Nodes (by 18F-FDG scan) | Experimental | Participants whose lymph nodes are positive for cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab-IRDye800 | Drug | 30 mg administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling | The ability of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG) to detect tumor in lymph nodes were assessed on the basis of radiologic scans and histopathologic evaluation of excised lymph nodes (LNs). The histopathologic assessment was considered the definitive, regular medical care, assessment. The outcome is reported by study group as the number of LNs that were identified as tumor-positive by 18F-FDG- and 89Zr-panitumumab, stratified by the tumor-positivity as assessed by histopathology, and expressed as the number of LNs that were tumor-positive by both, negative for both, or positive for one and not the other. Results are also provided by study group for the number of LNs that tumor-positive by both 18F-FDG- and 89Zr-panitumumab, negative for both, or positive for one and not the other. The outcome is numbers without dispersion | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of 89Zr-panitumumab, 18F-FDG, and Panitumumab-IRDye800 | The value of 89Zr-panitumumab and panitumumab-IRDye800 as a label for cancer cells (radiologic or fluorescent, respectively), was assessed by the sensitivity and specificity for the detection of tumor cells in lymph nodes near the tumor. 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use, was also assessed. Sensitivity was assessed as the "true positive rate" of paired measurements, expressed as the proportion (ratio) of the number of specimens positive by histopathology also positive by the test method (test:histopathology). Specificity is the "true negative rate", the proportion of the number of specimens negative by histopathology also negative by the test method. The closer the proportions are to 1, the greater the sensitivity or specificity. The outcome is reported as the sensitivity and specificity of 89Zr-panitumumab, panitumumab-IRDye800, and 18F-fluorodeoxyglucose (18F-FDG). The outcome results are ratios, a number without dispersion. |
| Measure | Description | Time Frame |
|---|---|---|
| 89Zr-panitumumab and 18F-FDG False-negatives | The value of experimental 89Zr-panitumumab as a radiologic label was assessed as the number of lymph nodes (LNs) that have false-negative results. A false-negative result in this study is one that does not indicate that cancer is present in the lymph node, when histopathologic evaluation confirms the presence of cancer in the lymph nodes. The outcome is reported as the number of false-negative lymph nodes observed after systemic labeling with 89Zr-panitumumab and 18F-FDG, an established agent for this use. The outcome results are numbers without dispersion. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru, MD | Stanford Medicine at Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tumor-negative Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are negative for cancer Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 89-Zirconium (Zr-89) Panitumumab | Drug | 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) |
|
|
| Pinpoint IR IR9000 fluorescence imaging system (FIS) | Device | Handheld fluorescence-imaging endoscope manufactured by Novadaq |
|
| SPY-PHI IR9000 fluorescence imaging system (FIS) | Device | Handheld fluorescence-imaging endoscope manufactured by Novadaq |
|
| Explorer Air camera | Device | Fluorescence camera manufactured by SurgVision |
|
| PDE-NEO II camera | Device | Medical infrared camera manufactured by Hamamatsu Photonics KK |
|
| FIS-00 fluorescence imaging system (FIS) | Device | Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK |
|
| Da Vinci Firefly Imaging System | Device | Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc |
|
| IGP-ELVIS-v4 Macroscopic Specimen Imager | Device | Macroscopic specimen imager manufactured by LI-COR Biosciences |
|
| Vevo 3100 LAZR-X | Device | Photoacoustic ultrasound imaging system manufactured by VisualSonics |
|
| Pearl Triology Imaging System | Device | Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences |
|
| Odyssey CLx Imaging System | Device | Infrared fluorescent-imaging system manufactured by LI-COR Biosciences |
|
| Leica fluorescence microscope | Device | Fluorescence microscope manufactured by Leica |
|
| up to 5 days |
| up to 5 days |
| Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 89Zr-panitumumab and 18F-FDG | The value of experimental 89Zr-panitumumab as a radiologic label was assessed by determining the positive predictive value (PPV) and the negative predictive value (NPV). PPV is a measure of extent that positive-labeled samples that were actually cancer, expressed as a proportion (ratio) of the number of positive-labeled samples vs samples positive by histopathology (positive label/positive histopathology). NPV is a measure of extent that negative-labeled samples (not positive) that were actually NOT cancer, expressed as a proportion (ratio) of the number of negative-labeled samples vs samples NOT positive by histopathology (negative label/negative histopathology). The closer the proportions are to 1, the better the predictive value. The outcome is reported as the PPV and NPV of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use. The outcome results are ratios, numbers without dispersion. | up to 5 days |
| FG001 | Tumor-positive Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are positive for cancer. Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence -imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tumor-negative Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are negative for cancer Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence-imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
| BG001 | Tumor-positive Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are positive for cancer. Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence-imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence-imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescenc3-imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Detection of Tumor in Lymph Nodes by 18F-FDG and 89Zr-panitumumab Labeling | The ability of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG) to detect tumor in lymph nodes were assessed on the basis of radiologic scans and histopathologic evaluation of excised lymph nodes (LNs). The histopathologic assessment was considered the definitive, regular medical care, assessment. The outcome is reported by study group as the number of LNs that were identified as tumor-positive by 18F-FDG- and 89Zr-panitumumab, stratified by the tumor-positivity as assessed by histopathology, and expressed as the number of LNs that were tumor-positive by both, negative for both, or positive for one and not the other. Results are also provided by study group for the number of LNs that tumor-positive by both 18F-FDG- and 89Zr-panitumumab, negative for both, or positive for one and not the other. The outcome is numbers without dispersion | Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies. | Posted | Number | Lymph Nodes | up to 5 days | Lymph nodes | Lymph nodes |
|
|
| ||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of 89Zr-panitumumab, 18F-FDG, and Panitumumab-IRDye800 | The value of 89Zr-panitumumab and panitumumab-IRDye800 as a label for cancer cells (radiologic or fluorescent, respectively), was assessed by the sensitivity and specificity for the detection of tumor cells in lymph nodes near the tumor. 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use, was also assessed. Sensitivity was assessed as the "true positive rate" of paired measurements, expressed as the proportion (ratio) of the number of specimens positive by histopathology also positive by the test method (test:histopathology). Specificity is the "true negative rate", the proportion of the number of specimens negative by histopathology also negative by the test method. The closer the proportions are to 1, the greater the sensitivity or specificity. The outcome is reported as the sensitivity and specificity of 89Zr-panitumumab, panitumumab-IRDye800, and 18F-fluorodeoxyglucose (18F-FDG). The outcome results are ratios, a number without dispersion. | Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies.Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies. | Posted | Number | Ratio | up to 5 days | Lymph nodes | Lymph nodes |
| ||||||||||||||||||||||||||
| Other Pre-specified | 89Zr-panitumumab and 18F-FDG False-negatives | The value of experimental 89Zr-panitumumab as a radiologic label was assessed as the number of lymph nodes (LNs) that have false-negative results. A false-negative result in this study is one that does not indicate that cancer is present in the lymph node, when histopathologic evaluation confirms the presence of cancer in the lymph nodes. The outcome is reported as the number of false-negative lymph nodes observed after systemic labeling with 89Zr-panitumumab and 18F-FDG, an established agent for this use. The outcome results are numbers without dispersion. | Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies. | Posted | Number | Lymph nodes | up to 5 days | Lymph nodes | Lymph nodes |
| ||||||||||||||||||||||||||
| Other Pre-specified | Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of 89Zr-panitumumab and 18F-FDG | The value of experimental 89Zr-panitumumab as a radiologic label was assessed by determining the positive predictive value (PPV) and the negative predictive value (NPV). PPV is a measure of extent that positive-labeled samples that were actually cancer, expressed as a proportion (ratio) of the number of positive-labeled samples vs samples positive by histopathology (positive label/positive histopathology). NPV is a measure of extent that negative-labeled samples (not positive) that were actually NOT cancer, expressed as a proportion (ratio) of the number of negative-labeled samples vs samples NOT positive by histopathology (negative label/negative histopathology). The closer the proportions are to 1, the better the predictive value. The outcome is reported as the PPV and NPV of 89Zr-panitumumab and 18F-fluorodeoxyglucose (18F-FDG), an established agent for this use. The outcome results are ratios, numbers without dispersion. | Some participants did not have lymph nodes collected, or the collected lymph nodes were not evaluable. Some lymph nodes were not evaluable by all methodologies. | Posted | Number | ratio | up to 5 days | Lymph nodes | Lymph nodes |
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tumor-negative Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are negative for cancer Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica | 0 | 7 | 1 | 7 | 7 | 7 |
| EG001 | Tumor-positive Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are positive for cancer. Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica | 0 | 7 | 0 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mobitz (type) II atrioventricular block | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Other, hypercarbia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, refeeding syndrome, mild | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Facial muscle weakness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglossal nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, fistula, nasal-oral, right | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Other, - Jackson-Pratt drain with serous drainage and tracheostomy site with mucinous secretion | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| Other, extravasation along anterior abdominal wall consistent with gastrostomy tube leak | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| Other, jejunostomy tube leak | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yu-Jin Lee, MD, MS | Stanford Medicine at Stanford University | 650-725-4711 | yujinlee@stanford.edu |
| Oct 25, 2022 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2021 | Oct 25, 2022 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| 89Zr-panitumumab-positive & pathology-negative |
|
|
| 89Zr-panitumumab-negative & pathology-positive |
|
|
| 89Zr-panitumumab-negative & pathology-negative |
|
|
| 18F-FDG-positive & pathology-positive |
|
|
| 18F-FDG-positive & pathology-negative |
|
|
| 18F-FDG-negative & pathology-positive |
|
|
| 18F-FDG-negative & pathology-negative |
|
|
| 89Zr-panitumumab-positive & 18F-FDG-positive |
|
|
| 89Zr-panitumumab-positive & 18F-FDG-negative |
|
|
| 89Zr-panitumumab-negative & 18F-FDG-positive |
|
|
| 89Zr-panitumumab-negative & 18F-FDG-negative |
|
|
| OG001 | Tumor-positive Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are positive for cancer. Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
|
|
| OG001 | Tumor-positive Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are positive for cancer. Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
|
|
| OG001 | Tumor-positive Lymph Nodes (by 18F-FDG Scan) | Participants whose lymph nodes are positive for cancer. Panitumumab-IRDye800: 30 mg administered intravenously (IV) Zirconium Zr-89 Panitumumab: 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV) Pinpoint IR IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq SPY-PHI IR9000 fluorescence imaging system (FIS): Handheld fluorescence-imaging endoscope manufactured by Novadaq Explorer Air camera: Fluorescence camera manufactured by SurgVision PDE-NEO II camera: Medical infrared camera manufactured by Hamamatsu Photonics KK FIS-00 fluorescence imaging system (FIS): Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK Da Vinci Firefly Imaging System: Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc IGP-ELVIS-v4 Macroscopic Specimen Imager: Macroscopic specimen imager manufactured by LI-COR Biosciences Vevo 3100 LAZR-X: Photoacoustic ultrasound imaging system manufactured by VisualSonics Pearl Triology Imaging System: Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences Odyssey CLx Imaging System: Infrared fluorescent imaging system manufactured by LI-COR Biosciences Leica fluorescence microscope: Fluorescence microscope manufactured by Leica |
|
|