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

NCT01659645 | Completed Early Phase 1 DMC

• 2 other identifiers: IRB00052551FACBCBr
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Presence of FACBC radiotracer in breast carcinoma on FACBC PET scan

  Outcomes will be assessed at the end of one year.

Study Arms (1)

FACBC

EXPERIMENTAL

Drug: FACBC

Interventions

FACBC DRUG

Drug FACBC will be given intravenously (IV) over 2 minutes prior to performing the PET scan

FACBC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years of age or older.
• 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.
• Ability to lie still for PET scanning
• Patients must be able to provide written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 8, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)