Parathyroid Disease Clinical Trial
Official title:
Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC
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 |
Verified date | June 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
David M. Schuster, MD |
United States,
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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