Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments positron emission tomography (pet), fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (facbc), positron emission mammography (pem) when available, mr
Phase phase 0
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator GE Healthcare
Start date May 2013
End date May 2017
Trial size 50 participants
Trial identifier NCT01864083, 11-177

Summary

This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
positron emission tomography (pet)
fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (facbc)
positron emission mammography (pem) when available
mr
(Experimental)
Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.
positron emission tomography (pet)
fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (facbc)
positron emission mammography (pem) when available

Primary Outcomes

Measure
assess the diagnostic accuracy
time frame: 2 years
ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy
time frame: 2 years

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC - No prior therapy for IDC or ILC - Clinical need for local disease staging with breast MR (Group A only) - Clinical need for neoadjuvant chemotherapy (Group B only) - Patients must provide written informed consent Exclusion Criteria: - Age <21 years - Men - Pregnancy or lactation - Patients who have already started treatment for the current malignancy - Patients who cannot undergo PET scanning (i.e. because of weight limits) - Patients who are known to have contraindication for MRI (e.g. metal implants) - Patients may only participate in group #1 or group #2, but not both

Additional Information

Official title FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Principal investigator Gary Ulaner, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.