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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00433 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PANC0024 | Other Identifier | OnCore | |
| P30CA124435 | U.S. NIH Grant/Contract | View source |
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Logistics
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.
This is a dose-escalation study of 50 mg or 100 mg cetuximab-IRDye800.
Clearance of the tumor margin during surgical resection of pancreatic cancer is clinical importance, as margin-positive resections are suspected to be associated with rapid emergence of distant metastases shortly after surgery. However, pancreatic cancer is known to be difficult to visualize intraoperatively. Nonetheless, better detection of tumor tissue might improve the rate of complete tumor clearance, thereby improving outcomes. However, in order to be actionable, the data from such enhanced tumor detection must be available during the resection procedure. This study evaluates the use of a dye, Cetuximab-IRDye 800CW, that is administered pre-surgery, and is detectable during the surgical procedure.
Florescent Imaging Cetuximab is a chimeric (mouse/human) monoclonal antibody that targets the epidermal growth factor (EGF) receptor (EGFR). EGFR is highly-expressed in pancreatic ductal adenocarcinoma (PDAC) and is a good target for antibody-mediated imaging, due to its transmembrane position. Cetuximab-IRDye 800CW is cetuximab labeled with IRDye800, an N-hydroxysuccinimide (NHS) ester infrared dye. IRDye800 has very similar properties compared to indocyanine green, and indocyanine green is readily detectable with a number of imaging systems. This study evaluates the Cetuximab-IRDye 800CW as a intraoperative labeling agent.
Patients receive Cetuximab-IRDye 800CW intravenously (IV) at 50 mg or 100 mg over 30 minutes to 1 hour on day 0. Within 2 to 5 days, patients undergo surgery with intraoperative imaging. Cetuximab-IRDye 800CW is used as part of a tumor-targeted molecular imaging procedure operating on the principles of differential accumulation of the antibody-dye conjugate in pancreatic tumor tissue vs normal pancreatic tissue vs pancreatitis tissue.
Excised tissues are prepared as formalin-fixed paraffin-embedded (FFPE) blocks for assessment of fluorescent intensity.
Photoacoustic imaging (PAI) For purposes of non-quantitative comparison, photoacoustic imaging (PAI) of the tumor lesions is also conducted. PAI refers to a non-invasive evaluation by ultrasound of the area of the resected tumor and surrounding tissue. PAI may have special utility for detecting tumors within 5 to 7 mm of depth, with a high degree of spatial resolution, which might be useful to enhance generation of tumor-free surgical margins. PAI does not utilize ionizing radiation, and should complement and conform to the findings from the fluorescent imaging.
PRIMARY OBJECTIVE:
Determine the efficacy of cetuximab-IRDye800 in intraoperatively identifying pancreatic cancer compared to surrounding normal pancreatic and extrapancreatic tissue, as measured by tumor-to-background ratio.
SECONDARY OBJECTIVE:
Determine the tolerability of the cetuximab IRDye800 as an imaging agent in patients undergoing resection of pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab IRDye800, 50 mg | Experimental | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. |
|
| Cetuximab IRDye800, 100 mg | Experimental | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab-IRDye800 | Drug | Administered intravenously (IV) at 50 or 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses | Cetuximab-IRDye800 (50 mg or 100 mg) was administered pre-operatively, and the uptake of the dye was assessed by observed fluorescence intra-operatively (ie, in vivo) and post-operatively (ex vivo, or "back table"), in tumorous (tumor or tumor-bearing lymph nodes) or normal (non-tumorous) tissues. Collectively, intra-operative and immediately post-operative are considered "peri-operative." The outcome tumor-to-background ratio (TBR) is measured as the mean of the ratios observed between tumor and normal tissue for the participants, and the outcome is expressed as the mean with standard deviation. | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo) | Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean counts/pixel for the cohort. The outcome is expressed as the mean counts/pixel with standard deviation. |
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INCLUSION CRITERIA
Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
≥ 19 years of age
Life expectancy of more than 12 weeks
EITHER
Hemoglobin ≥ 9 gm/dL
Platelet count ≥ 100,000/mm^3
Magnesium > the lower limit of normal (LLN) per institution normal lab values
Potassium > LLN
Calcium > LLN
Thyroid-stimulating hormone (TSH) < 13 micro International units/mL
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| George Poultsides, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17431103 | Background | Rosenthal EL, Kulbersh BD, King T, Chaudhuri TR, Zinn KR. Use of fluorescent labeled anti-epidermal growth factor receptor antibody to image head and neck squamous cell carcinoma xenografts. Mol Cancer Ther. 2007 Apr;6(4):1230-8. doi: 10.1158/1535-7163.MCT-06-0741. | |
| 16954995 | Background | Rosenthal EL, Kulbersh BD, Duncan RD, Zhang W, Magnuson JS, Carroll WR, Zinn K. In vivo detection of head and neck cancer orthotopic xenografts by immunofluorescence. Laryngoscope. 2006 Sep;116(9):1636-41. doi: 10.1097/01.mlg.0000232513.19873.da. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab IRDye800, 50 mg | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose |
| FG001 | Cetuximab IRDye800, 100 mg | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab IRDye800, 50 mg | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose |
| 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 |
| 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 | Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses | Cetuximab-IRDye800 (50 mg or 100 mg) was administered pre-operatively, and the uptake of the dye was assessed by observed fluorescence intra-operatively (ie, in vivo) and post-operatively (ex vivo, or "back table"), in tumorous (tumor or tumor-bearing lymph nodes) or normal (non-tumorous) tissues. Collectively, intra-operative and immediately post-operative are considered "peri-operative." The outcome tumor-to-background ratio (TBR) is measured as the mean of the ratios observed between tumor and normal tissue for the participants, and the outcome is expressed as the mean with standard deviation. | Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort in order to reduce variance/dispersion. | Posted | Mean | Standard Deviation | ratio | up to 5 days |
|
30 days +- one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetuximab IRDye800, 50 mg | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic fistula | Gastrointestinal disorders | 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eben Rosenthal | Stanford University | 650-723-2967 | elr@stanford.edu |
Not provided
| 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 9, 2016 | Nov 2, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| Cetuximab | Drug | Administered as a 100 mg IV loading dose |
|
|
| up to 14 days |
| Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity | Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as a mean with standard deviation, by dose. | up to 14 days |
| Sensitivity and Specificity of Ex Vivo Fluorescent Imaging | Sensitivity is the ability of a test to correctly identify patients with the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-positive patients. Sensitivity is defined as [TP/(TP+FN)], where TP=true-positive, and FN=false-negative. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as cancerous is confirmed by histology to be cancerous, and a lower % means reduced confidence in that result. Specificity is the ability of a test to correctly identify patients who do not have the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-negative patients. Specificity is defined as [TN/(TN+FP)], where TN=true-negative, and FP=false-positive. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as non-cancerous is confirmed by histology to be non-cancerous, and a lower % means reduced confidence in that result. | up to 14 days |
| Cetuximab-IRDye800 Tumor Detection in Lymph Nodes | Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in excised lymph nodes (ie, ex vivo) that were histologically-determined to be normal or tumor-bearing. Fluorescent intensity was measured in the image for each lymph using close-field fluorescence imaging and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as the mean MFI with standard deviation. | up to 14 days |
| Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI) | Photoacoustics were assessed as the signal-to-noise ratio (SNR), a unit-less number, as observed for tumor vs surrounding tissue using an ultrasound device. The value observed for tumor tissue is considered signal, and the value for normal tissue is considered noise. The more the ratio is greater than 1 reflects the more that the tumor tissue reflects an ultrasound signal compared to normal tissue. The outcome is expressed as the ratio of mean SNR signal for tumor tissue to normal tissue, without dispersion. | up to 5 days |
| Signal-to-Noise Ratio (SNR) by In Vivo Photoacoustic Imaging (PAI) | Photoacoustic imaging (PAI) was to be used to evaluate tumor and normal margin tissues (waste tissue) immediately peri-operatively (in vivo) and prior to pathological evaluation. The signal-to-noise ratio (SNR) as measured in dB of the tumor was to be calculated in the tumor specimens for comparison to surrounding normal tissue. The outcome would be expressed as the mean of the ratios, with standard deviation, and data used to qualitatively confirm the findings with Cetuximab-IRDye 800CW fluorescent imaging. | up to 5 days |
| Toxicity (≥ Grade 2) | Toxicity was assessed as the number of grade 2 or greater adverse events [Common Terminology Criteria for Adverse Events (CTCAE) version 4.03] determined to be clinically-significant and definitely-, probably-, or possibly-related to cetuximab-IRDye 800CW. The outcome is reported as the number of treatment-related adverse events ≥ grade 2 without dispersion, by dose level. | Up to 30 days |
| 29667116 | Result | Tummers WS, Miller SE, Teraphongphom NT, Gomez A, Steinberg I, Huland DM, Hong S, Kothapalli SR, Hasan A, Ertsey R, Bonsing BA, Vahrmeijer AL, Swijnenburg RJ, Longacre TA, Fisher GA, Gambhir SS, Poultsides GA, Rosenthal EL. Intraoperative Pancreatic Cancer Detection using Tumor-Specific Multimodality Molecular Imaging. Ann Surg Oncol. 2018 Jul;25(7):1880-1888. doi: 10.1245/s10434-018-6453-2. Epub 2018 Apr 17. |
| 32416765 | Derived | Lwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available. |
| BG001 |
| Cetuximab IRDye800, 100 mg |
On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 or 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose |
|
|
| Secondary | Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo) | Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean counts/pixel for the cohort. The outcome is expressed as the mean counts/pixel with standard deviation. | Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort in order to reduce variance/dispersion. | Posted | Mean | Standard Deviation | counts per pixel | up to 14 days |
|
|
|
| Secondary | Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity | Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as a mean with standard deviation, by dose. | Tissue sampling and labeling can be imprecise, and there may not have been residual tissue after standard-of-care pathological analysis. Data were not obtained for all participants. | Posted | Mean | Standard Deviation | counts per pixel | up to 14 days |
|
|
|
| Secondary | Sensitivity and Specificity of Ex Vivo Fluorescent Imaging | Sensitivity is the ability of a test to correctly identify patients with the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-positive patients. Sensitivity is defined as [TP/(TP+FN)], where TP=true-positive, and FN=false-negative. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as cancerous is confirmed by histology to be cancerous, and a lower % means reduced confidence in that result. Specificity is the ability of a test to correctly identify patients who do not have the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-negative patients. Specificity is defined as [TN/(TN+FP)], where TN=true-negative, and FP=false-positive. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as non-cancerous is confirmed by histology to be non-cancerous, and a lower % means reduced confidence in that result. | Outcome results for sensitivity and specificity of fluorescent imaging were available by dose, and compiled across both doses. Tissue sampling and labeling can be imprecise, and there may not have been residual tissue after standard-of-care pathological analysis. Data were not obtained for all participants. | Posted | Number | percentage of lymph nodes | up to 14 days | Lymph nodes | Lymph nodes |
|
|
|
| Secondary | Cetuximab-IRDye800 Tumor Detection in Lymph Nodes | Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in excised lymph nodes (ie, ex vivo) that were histologically-determined to be normal or tumor-bearing. Fluorescent intensity was measured in the image for each lymph using close-field fluorescence imaging and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as the mean MFI with standard deviation. | The relationship of the number of participants to number of analyzed lymph nodes (tumor-bearing or not) is not 1:1, & tissue sampling & labeling are imprecise. Participants could contribute none or multiple normal and tumor-bearing lymph node for analysis. Data were not obtained for all participants. | Posted | Mean | Standard Error | counts per pixel | up to 14 days | Lymph nodes | Lymph nodes |
|
|
|
| Secondary | Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI) | Photoacoustics were assessed as the signal-to-noise ratio (SNR), a unit-less number, as observed for tumor vs surrounding tissue using an ultrasound device. The value observed for tumor tissue is considered signal, and the value for normal tissue is considered noise. The more the ratio is greater than 1 reflects the more that the tumor tissue reflects an ultrasound signal compared to normal tissue. The outcome is expressed as the ratio of mean SNR signal for tumor tissue to normal tissue, without dispersion. | Tissue sampling and labeling can be imprecise. Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort. Data were not obtained for all participants. Dispersion was not and can not be determined for the outcome, a ratio (ratio of means). | Posted | Number | ratio | up to 5 days |
|
|
|
| Secondary | Signal-to-Noise Ratio (SNR) by In Vivo Photoacoustic Imaging (PAI) | Photoacoustic imaging (PAI) was to be used to evaluate tumor and normal margin tissues (waste tissue) immediately peri-operatively (in vivo) and prior to pathological evaluation. The signal-to-noise ratio (SNR) as measured in dB of the tumor was to be calculated in the tumor specimens for comparison to surrounding normal tissue. The outcome would be expressed as the mean of the ratios, with standard deviation, and data used to qualitatively confirm the findings with Cetuximab-IRDye 800CW fluorescent imaging. | The in vivo photoacoustic imaging (PAI) component of this study was not IRB-approved, and this part of the study was not conducted. | Posted | up to 5 days |
|
|
| Secondary | Toxicity (≥ Grade 2) | Toxicity was assessed as the number of grade 2 or greater adverse events [Common Terminology Criteria for Adverse Events (CTCAE) version 4.03] determined to be clinically-significant and definitely-, probably-, or possibly-related to cetuximab-IRDye 800CW. The outcome is reported as the number of treatment-related adverse events ≥ grade 2 without dispersion, by dose level. | Posted | Number | Adverse events | Up to 30 days |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Cetuximab IRDye800, 100 mg | On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days. Cetuximab-IRDye800: Administered intravenously (IV) at 50 or 100 mg Cetuximab: Administered as a 100 mg IV loading dose | 0 | 2 | 0 | 2 | 2 | 2 |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Pancreatic tumor tissue |
|
| Title | Measurements |
|---|---|
|
|
| Histologically normal lymph nodes |
|
|