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

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ClinicalTrials.gov Identifier: NCT01574287
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University

Tracking Information
First Submitted Date  ICMJE March 31, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE June 14, 2019
Results First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ]
Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Correlate uptake of anti-3-[18F]FACBC to surgical findings of parathyroid adenomas [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ]
To evaluate if anti-3-[18F]FACBC can detect parathyroid adenomas.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool [ Time Frame: 5-10 min after intravenous bolus injection of [18F]fluciclovine ]
To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Measure uptake mechanisms of anti-3-[18F]FACBC in parathyroid adenomas [ Time Frame: At approximately 1 month post scan (time of surgery and pathologic analysis) ]
To evaluate uptake mechanisms and specific amino acid transporter regulation of anti-3-[18F]FACBC in parathyroid adenomas.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
Official Title  ICMJE Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Parathyroid Disease
Intervention  ICMJE Drug: FACBC
Drug is give intravenously over 2 minutes at time of scan
Study Arms  ICMJE Experimental: FACBC
Intervention: Drug: FACBC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
12
Actual Study Completion Date  ICMJE May 15, 2019
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574287
Other Study ID Numbers  ICMJE IRB00051415
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David M. Schuster, MD, Emory University
Study Sponsor  ICMJE David M. Schuster, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Schuster, MD Emory University
PRS Account Emory University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP