Trials / Terminated
TerminatedNCT02708511
Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer
64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Sanjiv Sam Gambhir · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer cells such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu 64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better treatment.
Detailed description
PRIMARY OBJECTIVES: I. To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab). SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Computed Tomography | Undergo PET/CT |
| DRUG | Copper Cu 64-DOTA B-Fab | Given IV |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| OTHER | Pharmacological Study | Correlative studies |
| DIAGNOSTIC_TEST | Positron Emission Tomography | Undergo PET/CT |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2017-10-11
- Completion
- 2017-10-11
- First posted
- 2016-03-15
- Last updated
- 2018-04-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02708511. Inclusion in this directory is not an endorsement.