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

Sanjiv Sam Gambhir

Status and phase: Terminated; Phase 1

Conditions: Ovarian Carcinoma; Breast Carcinoma

Treatments: Diagnostic Test: Positron Emission Tomography; Other: Pharmacological Study; Drug: Copper Cu 64-DOTA B-Fab; Diagnostic Test: Computed Tomography; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02708511

IRB-32991 (Other Identifier)

32991

GYNOVA0033 (Other Identifier)

NCI-2015-00767 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Diagnostic (Cu 64 DOTA-B-Fab)

Experimental group

Description:

Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection

Treatment:

Drug: Copper Cu 64-DOTA B-Fab

Diagnostic Test: Computed Tomography

Other: Pharmacological Study

Other: Laboratory Biomarker Analysis

Diagnostic Test: Positron Emission Tomography