Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
Primary Purpose
Parathyroid Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FACBC
Sponsored by
About this trial
This is an interventional diagnostic trial for Parathyroid Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FACBC
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01574287
Brief Title
Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
Official Title
Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David M. Schuster, MD
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FACBC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FACBC
Intervention Description
Drug is give intravenously over 2 minutes at time of scan
Primary Outcome Measure Information:
Title
Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality
Description
Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.
Time Frame
At approximately 1 month post scan (time of surgery and pathologic analysis)
Secondary Outcome Measure Information:
Title
Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool
Description
To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed
Time Frame
5-10 min after intravenous bolus injection of [18F]fluciclovine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Schuster, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
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