Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|