Breast Carcinoma, Ovarian Carcinoma
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTComputed Tomography
Undergo PET/CT
DRUGCopper Cu 64-DOTA B-Fab
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERPharmacological Study
Correlative studies
DIAGNOSTIC_TESTPositron Emission Tomography
Undergo PET/CT
Sponsors
Sanjiv Sam Gambhir
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ovarian Cancer Participants 1. Patient is ≥ 18 years old at the time of the drug administration 2. Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR Participant has biopsy proven ovarian cancer but is not a surgical candidate 3. Ability to understand and the willingness to sign a written informed consent document. 4. Patient is able to remain still for duration of each imaging procedure Breast Cancer Participants 1. Patient is ≥ 18 years old at the time of the drug administration 2. Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s) 3. Ability to understand and the willingness to sign a written informed consent document. 4. Patient is able to remain still for duration of each imaging procedure
Exclusion criteria
Ovarian Cancer Participants 1. Patient is pregnant or breast-feeding 2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures. 3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements 4. Patients participating in other research imaging protocols will be excluded from this study. Breast Cancer Participants 1. Patient is pregnant or breast-feeding 2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures. 3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements 4. Patients participating in other research imaging protocols will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of copper Cu 64 DOTA-B-Fab | 24 hours | Determined from serial imaging correlated with blood and urine samples. |
| Dosimetry of copper Cu 64 DOTA-B-Fab | 120 minutes post-injection | Determined from serial imaging correlated with blood and urine samples. |
Countries
United States
Outcome results
None listed