Anti-1-amino-3-[18F]Fluorocyclobutyl-1-carboxylic Acid (Anti-[18F](FACBC)Positron Emission Tomography (PET-CT) of the Breast

Emory University

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

Treatments: Drug: FACBC

Study type: Interventional

Funder types: Other

Identifiers

NCT01659645

FACBCBr (Other Identifier)

IRB00052551

Details and patient eligibility

About

Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010 leading to 39,840 cancer related deaths.

Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become the a standard method for isolating the tumor. However, FDG is insensitive in small breast tumors and certain histologic types such as lobular, certain types of breast carcinoma. In addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging tool that increases the ability to characterize detect breast carcinoma and to detect locoregional spread, as well as monitor therapeutic treatment response.

anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments,FACBC has shown uptake in the breast tumor cell line.

The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics via time-activity curves from dynamic imaging characteristics. The investigators will enroll 12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The investigators will then compare findings to determine if this radiotracer is worthy of further study in a more comprehensive experiment.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be 18 years of age or older.
2. Patients will have a breast mass and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. Patients with known or suspected recurrent disease will be eligible for this protocol.
3. Ability to lie still for PET scanning
4. Patients must be able to provide written informed consent

Exclusion criteria

1. Age less than 18.
2. Inability to lie still for PET scanning.
3. Cannot provide written informed consent.
4. Current therapy for breast carcinoma.
5. Positive serum or urine pregnancy test within 24 hours of study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

FACBC

Experimental group

Treatment:

Drug: FACBC