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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659645
First Posted: August 8, 2012
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University
  Purpose

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.


Condition Intervention Phase
Breast Cancer Drug: FACBC Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Amino Acid Transport Imaging of Breast Carcinoma Via Anti-3-[18F]FACBC PET-CT: A Pilot Study

Resource links provided by NLM:


Further study details as provided by David M. Schuster, MD, Emory University:

Primary Outcome Measures:
  • Presence of FACBC radiotracer in breast carcinoma on FACBC PET scan [ Time Frame: Outcomes will be assessed at the end of one year. ]

Enrollment: 12
Study Start Date: August 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FACBC Drug: FACBC
Drug FACBC will be given intravenously (IV) over 2 minutes prior to performing the PET scan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659645


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
  More Information

Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01659645     History of Changes
Other Study ID Numbers: IRB00052551
FACBCBr ( Other Identifier: Other )
First Submitted: August 1, 2012
First Posted: August 8, 2012
Last Update Posted: October 27, 2016
Last Verified: October 2016