Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer
|ClinicalTrials.gov Identifier: NCT02708511|
Recruitment Status : Terminated
First Posted : March 15, 2016
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma Breast Carcinoma||Diagnostic Test: Computed Tomography Drug: Copper Cu 64-DOTA B-Fab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Diagnostic Test: Positron Emission Tomography||Phase 1|
I. To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).
I. To evaluate the safety of 64Cu-DOTA B-Fab single administration.
II. To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast cancer lesions.
III. To compare PET results with the immunohistochemistry (IHC) analysis of the excised tumor samples.
Patients receive copper Cu 64-DOTA-B-Fab intravenously (IV) followed by PET/CT 60 minutes post-injection and 24 hours post-injection
After completion of study, patients are followed up for 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||October 11, 2017|
|Actual Study Completion Date :||October 11, 2017|
Experimental: Diagnostic (Cu 64 DOTA-B-Fab)
Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
Diagnostic Test: Computed Tomography
Drug: Copper Cu 64-DOTA B-Fab
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Diagnostic Test: Positron Emission Tomography
- Biodistribution of copper Cu 64 DOTA-B-Fab [ Time Frame: 24 hours ]Determined from serial imaging correlated with blood and urine samples.
- Dosimetry of copper Cu 64 DOTA-B-Fab [ Time Frame: 120 minutes post-injection ]Determined from serial imaging correlated with blood and urine samples.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708511
|United States, California|
|Stanford University, School of Medicine|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Sanjiv Gambhir||Stanford University|