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

Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC

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.

Study Overview

• Status: Completed
• Conditions: Parathyroid Disease
• Intervention / Treatment: Drug: FACBC

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30032
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: David M. Schuster, MD
• Investigators: Principal Investigator: David M Schuster, MD, Emory University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: March 31, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Adenoma; Parathyroid Neoplasms; Parathyroid Diseases
• Other Study ID Numbers: IRB00051415