Trial Outcomes & Findings for 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer (NCT NCT01939275)
NCT ID: NCT01939275
Last Updated: 2025-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
n=8 Participants
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.
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|---|---|
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Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
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Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
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2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearThe 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.
Outcome measures
| Measure |
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
n=8 Participants
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.
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|---|---|
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Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
HER2 Negative, Tumor Visual Negative
|
5 participants
|
|
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
HER 2 Positive, Tumor Visual Negative
|
1 participants
|
|
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
HER 2 Equivocal, Tumor Visual Negative
|
2 participants
|
|
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
HER2 Negative, Tumor Visual Positive
|
0 participants
|
|
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
HER 2 Positive, Tumor Visual Positive
|
0 participants
|
|
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
HER 2 Equivocal, Tumor Visual Positive
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0 participants
|
Adverse Events
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
n=8 participants at risk
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.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
37.5%
3/8 • Number of events 3 • 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.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • 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.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • 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.
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • 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.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Investigations
Blood bilirubin increased
|
25.0%
2/8 • Number of events 2 • 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.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Acidosis
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
37.5%
3/8 • Number of events 3 • 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.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
2/8 • Number of events 2 • 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.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • Number of events 3 • 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.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
37.5%
3/8 • Number of events 3 • 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.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
12.5%
1/8 • Number of events 1 • 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.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place