Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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64Cu-DOTA-B-Fab as A PET Tracer for Evaluating CA6 Expression in Tumors: A First in Human Study

Conditions
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Ovarian Carcinoma, Breast Carcinoma

Intervention / Treatment
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* Diagnostic Test: Computed Tomography
* Drug: Copper Cu 64-DOTA B-Fab
* Other: Laboratory Biomarker Analysis
* Other: Pharmacological Study
* Diagnostic Test: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ovarian Cancer Participants Patient is ≥ 18 years old at the time of the drug administration 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 Ability to understand and the willingness to sign a written informed consent document. Patient is able to remain still for duration of each imaging procedure Breast Cancer Participants Patient is ≥ 18 years old at the time of the drug administration Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s) Ability to understand and the willingness to sign a written informed consent document. Patient is able to remain still for duration of each imaging procedure Exclusion Criteria: Ovarian Cancer Participants Patient is pregnant or breast-feeding Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements Patients participating in other research imaging protocols will be excluded from this study. Breast Cancer Participants Patient is pregnant or breast-feeding Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements Patients participating in other research imaging protocols will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (Cu 64 DOTA-B-Fab)<br>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<br>* Undergo PET/CT<br>* Other names: tomography;Drug: Copper Cu 64-DOTA B-Fab<br>* Given IV<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Pharmacological Study<br>* Correlative studies<br>Diagnostic Test: Positron Emission Tomography<br>* Undergo PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of copper Cu 64 DOTA-B-Fab | Determined from serial imaging correlated with blood and urine samples. | 24 hours | 
| Dosimetry of copper Cu 64 DOTA-B-Fab | Determined from serial imaging correlated with blood and urine samples. | 120 minutes post-injection |