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64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01939275
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Adenocarcinoma of the Gastroesophageal Junction
Diffuse Adenocarcinoma of the Stomach
Intestinal Adenocarcinoma of the Stomach
Mixed Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IA Gastric Cancer
Stage IB Gastric Cancer
Stage IIA Gastric Cancer
Stage IIB Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer
Stage IV Gastric Cancer
Interventions Radiation: copper Cu 64-DOTA-trastuzumab
Device: positron emission tomography
Other: laboratory biomarker analysis
Procedure: Computed Tomography
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
64
(50 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Asian
6
  75.0%
Hispanic
2
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Correlation of HER2 Expression With Uptake of 64Cu-DOTA-trastuzumab by PET Imaging.
Hide Description 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.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
HER2 Negative, Tumor Visual Negative 5
HER 2 Positive, Tumor Visual Negative 1
HER 2 Equivocal, Tumor Visual Negative 2
HER2 Negative, Tumor Visual Positive 0
HER 2 Positive, Tumor Visual Positive 0
HER 2 Equivocal, Tumor Visual Positive 0
Time Frame Adverse events were collected over a period of 2 years and 4 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Hide Arm/Group Description 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.
All-Cause Mortality
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic (Copper Cu 64-DOTA-trastuzumab PET Scan)
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Anemia *  3/8 (37.50%)  3
Cardiac disorders   
Sinus tachycardia *  1/8 (12.50%)  1
Gastrointestinal disorders   
Abdominal distension *  1/8 (12.50%)  1
Abdominal pain *  1/8 (12.50%)  1
Diarrhea *  1/8 (12.50%)  1
General disorders   
Chills *  1/8 (12.50%)  1
Edema limbs *  1/8 (12.50%)  1
Fatigue *  1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Bruising *  1/8 (12.50%)  1
Investigations   
Alanine aminotransferase increased *  1/8 (12.50%)  1
Aspartate aminotransferase increased *  1/8 (12.50%)  1
Blood bilirubin increased *  2/8 (25.00%)  2
Platelet count decreased *  1/8 (12.50%)  1
Weight loss *  1/8 (12.50%)  1
Metabolism and nutrition disorders   
Acidosis *  1/8 (12.50%)  1
Anorexia *  1/8 (12.50%)  1
Hypercalcemia *  1/8 (12.50%)  1
Hypoalbuminemia *  3/8 (37.50%)  3
Hypocalcemia *  2/8 (25.00%)  2
Hypokalemia *  1/8 (12.50%)  1
Hyponatremia *  3/8 (37.50%)  3
Hypophosphatemia *  3/8 (37.50%)  3
Nervous system disorders   
Headache *  1/8 (12.50%)  1
Somnolence *  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Sore throat *  1/8 (12.50%)  1
Tachypnea *  1/8 (12.50%)  1
Vascular disorders   
Hypertension *  1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-812-5265
EMail: pfrankel@coh.org
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01939275     History of Changes
Other Study ID Numbers: 13229
NCI-2013-01721 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
13229 ( Other Identifier: City of Hope Medical Center )
First Submitted: September 6, 2013
First Posted: September 11, 2013
Results First Submitted: September 18, 2019
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019