FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Study Type
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: Positron Emission Tomography (PET) Type: Procedure
Name: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) Type: Drug
Name: Positron emission mammography (PEM) When available Type: Procedure
Name: MR Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
Criteria: 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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Gary Ulaner, MD,PhD - 212-639-3776
Start Date
May 2013
Completion Date
May 2016
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page