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

NCT01574287 | Completed Results DMC

• 1 other identifier: IRB00051415
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parathyroid Disease

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality

  Detection rate of parathyroid adenomas using anti-3-\[18F\]FACBC modality is assessed by comparing \[18F\]FACBC and surgical findings.

  At approximately 1 month post scan (time of surgery and pathologic analysis)

Secondary Outcomes (1)

• Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool

  5-10 min after intravenous bolus injection of [18F]fluciclovine

Study Arms (1)

FACBC

EXPERIMENTAL

Drug: FACBC

Interventions

FACBC DRUG

Drug is give intravenously over 2 minutes at time of scan

FACBC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years of age or older.
• Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery .
• Ability to lie still for PET scanning
• Patients must be able to provide written informed consent

You may not qualify if:

• Age less than 18.
• Inability to lie still for PET scanning.
• Cannot provide written informed consent.
• History of secondary hyperparathyroidism.
• Positive serum or urine pregnancy test within 24 hours of imaging

Sponsors & Collaborators

• David M. Schuster, MD: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30032, United States

Location

MeSH Terms

Conditions

Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Results Point of Contact

• Title: Schuster, David
• Organization: Emory University

dschust@emory.edu

404-712-4859

Study Officials

• David M Schuster, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 31, 2012
• First Posted: April 10, 2012
• Study Start: August 1, 2012
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

US (1)