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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01574287
Other study ID # IRB00051415
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date May 15, 2019

Study information

Verified date June 2019
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date May 15, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Drug:
FACBC
Drug is give intravenously over 2 minutes at time of scan

Locations

Country Name City State
United States Emory University Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
David M. Schuster, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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Completed NCT01539486 - Relationship of Preoperative Parathyroid Hormone (PTH) and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy