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

• 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: David M. Schuster, MD
• Information provided by (Responsible Party): David M. Schuster, MD, Emory University

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30032

Sponsors and Collaborators

David M. Schuster, MD

Investigators

• 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

More Information

• Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT01574287
• Other Study ID Numbers: IRB00051415
• First Posted: April 10, 2012
• Results First Posted: July 2, 2019
• Last Update Posted: July 2, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

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