Trial record 2 of 65 for:    Open Studies | "Parathyroid Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01574287
First received: March 31, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Parathyroid Disease
Drug: FACBC

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    To evaluate if anti-3-[18F]FACBC can detect parathyroid adenomas.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    To evaluate uptake mechanisms and specific amino acid transporter regulation of anti-3-[18F]FACBC in parathyroid adenomas.


Estimated Enrollment: 12
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FACBC Drug: FACBC
Drug is give intravenously over 2 minutes at time of scan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574287

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30032
Contact: Leah Bellamy, RN, MSN    404-712-7965    lbellam@emory.edu   
Contact: David Schuster, MD    404-712-4859    dschust@emory.edu   
Sub-Investigator: Colin Weber, MD         
Sub-Investigator: Raghu Halkar, MD         
Sub-Investigator: Jyotirmay Sharma, MD         
Sponsors and Collaborators
David M. Schuster, MD
Investigators
Principal Investigator: David M Schuster, MD Emory University
  More Information

No publications provided

Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01574287     History of Changes
Other Study ID Numbers: IRB00051415
Study First Received: March 31, 2012
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenoma
Parathyroid Diseases
Parathyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014