Breast Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

2

Study ID:

NCT02708511

Recruitment Status:

Terminated

Sponsor:

Sanjiv Sam Gambhir

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There is 1 Location for this study

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Stanford University, School of Medicine
Palo Alto California, 94304, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

2

Study ID:

NCT02708511

Recruitment Status:

Terminated

Sponsor:


Sanjiv Sam Gambhir

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