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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574287
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
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
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ]
    Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.


Secondary Outcome Measures :
  1. Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool [ Time Frame: 5-10 min after intravenous bolus injection of [18F]fluciclovine ]
    To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed



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

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 ClinicalTrials.gov identifier (NCT number): NCT01574287


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30032
Sponsors and Collaborators
David M. Schuster, MD
Investigators
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Principal Investigator: David M Schuster, MD Emory University
  Study Documents (Full-Text)

Documents provided by David M. Schuster, MD, Emory University:
Study Protocol  [PDF] November 22, 2013
Statistical Analysis Plan  [PDF] June 13, 2019

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Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01574287    
Other Study ID Numbers: IRB00051415
First Posted: April 10, 2012    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Parathyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms