FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer

NCT ID: NCT00917865

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-01-31

Brief Summary

The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.

The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.

The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.

Conditions

Prostate Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FACBC Imaging

Dynamic FACBC PET of primary prostate carcinoma.

Group Type: EXPERIMENTAL

anti [18F]FACBC

Intervention Type: DRUG

Anti\[18F\]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.

Interventions

anti [18F]FACBC

Anti\[18F\]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must be 18 years of age or older.
• Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate cancer.
• Ability to lie still for PET scanning
• Patients must be able to provide written informed consent.

Exclusion Criteria

• Age less than 18
• Inability to lie still for PET scanning
• Cannot provide written informed consent.
• Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake from inflammation).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

David M. Schuster, MD

OTHER

Sponsor Role: lead

Responsible Party

David M. Schuster, MD

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

References

Schuster DM, Taleghani PA, Nieh PT, Master VA, Amzat R, Savir-Baruch B, Halkar RK, Fox T, Osunkoya AO, Moreno CS, Nye JA, Yu W, Fei B, Wang Z, Chen Z, Goodman MM. Characterization of primary prostate carcinoma by anti-1-amino-2-[(18)F] -fluorocyclobutane-1-carboxylic acid (anti-3-[(18)F] FACBC) uptake. Am J Nucl Med Mol Imaging. 2013;3(1):85-96. Epub 2013 Jan 5.

Reference Type: RESULT

PMID: 23342303 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3545368/

Click here for more information on this study

Other Identifiers

FACBC

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00008094

Identifier Type: -

Identifier Source: org_study_id