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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01721 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 13229 | Other Identifier | City of Hope Medical Center |
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This pilot clinical trial studies copper Cu 64 (64Cu) tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET)/computed tomography (CT) in studying patients with gastric, or stomach cancer. Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab PET/CT, may help doctors study the characteristics of tumors and choose the best treatment.
PRIMARY OBJECTIVES:
I. To compare tumor uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) in gastric cancer patients with pathologic evaluation of tumor human epidermal growth factor receptor 2 (HER2)/neu expression.
II. To compare copper Cu 64-DOTA-trastuzumab-PET-CT scan with standard radiographic imaging for staging patients with gastric cancer.
OUTLINE:
Patients receive copper Cu 64-DOTA-trastuzumab intravenously (IV) on day 1 and then undergo PET/CT scan on days 2 or 3.
After completion of study, patients are followed up for 15 days and periodically for up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan) | Experimental | Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| copper Cu 64-DOTA-trastuzumab | Radiation | Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings | The reading of the 64CuDOTA-trastuzumab-PET imaging of the study subjects were performed by two radiologists, one who read the first scan and the second nuclear radiologist read the remaining seven scans. To eliminate potential bias, the second nuclear radiologist was blinded to the HER2 status of the tumors as well as the location of the tumor until radiolabeled uptake was measured. XD (version 3.6; Miranda Medical) was used for image analysis.Tumor visualized as "hot" relative to adjacent tissue reported per radiologist as negative, positive, equivocal or unknown. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanghee Woo, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan) | Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Apr 26, 2017 |
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| positron emission tomography | Device | Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan |
|
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| laboratory biomarker analysis | Other | Correlative studies |
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| Computed Tomography | Procedure | Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan |
|
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| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan) | Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings | The reading of the 64CuDOTA-trastuzumab-PET imaging of the study subjects were performed by two radiologists, one who read the first scan and the second nuclear radiologist read the remaining seven scans. To eliminate potential bias, the second nuclear radiologist was blinded to the HER2 status of the tumors as well as the location of the tumor until radiolabeled uptake was measured. XD (version 3.6; Miranda Medical) was used for image analysis.Tumor visualized as "hot" relative to adjacent tissue reported per radiologist as negative, positive, equivocal or unknown. | Posted | Number | participants | Up to 1 year |
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Adverse events were collected over a period of 2 years and 4 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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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 | Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan) | Patients will receive 45 mg trastuzumab over 15 minutes prior to the administration of 64Cu -DOTA-trastuzumab, which includes 5 mg of trastuzumab. Imaging will be performed on a GE Discovery 16 Ste PET-CT scanner (axial field of view 15.4 cm). PET-CT images will be performed in 3D mode (septa retracted) and corrected for tissue attenuation based on co-registered CT acquired during the same examination. PET-CT images will be reconstructed with spatial resolution of approximately 9 mm full-width-at-half maximum using an iterative algorithm. Patients will be injected via a peripheral vein with 15 mCi of 64Cu-DOTA-trastuzumab. PET-CT scanning of 64Cu will be performed between 24 and 48 hours post injection. At 24 hours, the concentration of 64Cu-DOTA-trastuzumab will allow for whole body PET-CT imaging within the same amount of time required to image the abdomen and pelvis at 48 hours due to the half life of the radiotracer. PET-CT images will be compared to standard MRI or CT scans. | 0 | 8 | 0 | 8 | 8 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Edema limbs | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | Non-systematic Assessment |
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| Platelet count decreased | Investigations | Non-systematic Assessment |
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| Weight loss | Investigations | Non-systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Tachypnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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A total of 8 of the planned 22 gastric adenocarcinoma subjects met eligibility and completed the imaging with 64CuDOTA-Trastuzumab-PET/CT during the 3-year grant period.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-812-5265 | pfrankel@coh.org |
| Oct 9, 2019 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C546788 | 64Cu-DOTA-trastuzumab |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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| Title | Measurements |
|---|---|
|
| HER2 Negative, Tumor Visual Positive |
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| HER 2 Positive, Tumor Visual Positive |
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| HER 2 Equivocal, Tumor Visual Positive |
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