FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Positron Emission Tomography (PET); Procedure: Positron emission mammography (PEM) When available; Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC); Procedure: MR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01864083

11-177

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Local staging patients

Experimental group

Description:

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.

Treatment:

Procedure: Positron emission mammography (PEM) When available

Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Procedure: MR

Procedure: Positron Emission Tomography (PET)

Neoadjuvant chemotherapy patients

Experimental group

Description:

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.

Treatment:

Procedure: Positron emission mammography (PEM) When available

Drug: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)

Procedure: Positron Emission Tomography (PET)