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

Trial ID or NCT#

NCT02708511

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
  1. 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.
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Investigator(s)

Sanjiv Sam Gambhir, MD, PhD

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov