Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01574287
Recruitment Status : Recruiting
First Posted : April 10, 2012
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University

Brief Summary:

Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a small growth called an adenoma in the parathyroid glands) is an increasingly significant medical and public health condition.

Surgery is the only effective management for primary hyperparathyroidism. However; it is sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of tumors.

SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing the tumor. This, however, is a challenge because the parathyroid glands usually are located close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the parathyroid but not in the thyroid.

A more sensitive and specific radiotracer/tracking agent would markedly improve the investigators ability to identify parathyroid tumors preoperatively, and thus offer more patients a minimally invasive parathyroidectomy.

anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.

The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates uptake within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will undergo PET-CT using anti-3-[18F]FACBC in addition to the standard 99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery routinely, the investigators will then compare findings at surgery to those of the anti-3-[18F]FACBC PET-CT to determine if this radiotracer is worthy of further study in a more comprehensive experiment.

Condition or disease Intervention/treatment Phase
Parathyroid Disease Drug: FACBC Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC
Study Start Date : August 2012
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: FACBC Drug: FACBC
Drug is give intravenously over 2 minutes at time of scan

Primary Outcome Measures :
  1. Correlate uptake of anti-3-[18F]FACBC to surgical findings of parathyroid adenomas [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ]
    To evaluate if anti-3-[18F]FACBC can detect parathyroid adenomas.

Secondary Outcome Measures :
  1. Measure uptake mechanisms of anti-3-[18F]FACBC in parathyroid adenomas [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ]
    To evaluate uptake mechanisms and specific amino acid transporter regulation of anti-3-[18F]FACBC in parathyroid adenomas.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must be 18 years of age or older.
  2. Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery .
  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. History of secondary hyperparathyroidism.
  5. Positive serum or urine pregnancy test within 24 hours of imaging

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 identifier (NCT number): NCT01574287

Contact: Bridget Fielder 404-778-5625

United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30032
Contact: Leah Bellamy, RN, MSN    404-712-7965   
Contact: David Schuster, MD    404-712-4859   
Sub-Investigator: Colin Weber, MD         
Sub-Investigator: Raghu Halkar, MD         
Sub-Investigator: Jyotirmay Sharma, MD         
Sponsors and Collaborators
David M. Schuster, MD
Principal Investigator: David M Schuster, MD Emory University

Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University Identifier: NCT01574287     History of Changes
Other Study ID Numbers: IRB00051415
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Parathyroid Diseases
Parathyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms