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18F-Fluorocholine for the Detection of Parathyroid Adenomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03764007
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : August 5, 2020
Information provided by (Responsible Party):
Insoo Suh, MD, University of California, San Francisco

Brief Summary:
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Primary Drug: Fluorocholine PET Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Fluorocholine for the Detection of Parathyroid Adenomas
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Fluorocholine PET arm
Patients will undergo a single fluorocholine PET imaging study prior to surgery.
Drug: Fluorocholine PET
Imaging study using PET after the injection of the fluorocholine radio tracer

Primary Outcome Measures :
  1. Sensitivity for the detection of the abnormal parathyroid adenoma. [ Time Frame: Through time of parathyroidectomy, an average of 1 year ]
    Sensitivity of imaging in comparison to pathology at surgery. Location of parathyroid adenoma at imaging as read by three blinded readers, will be correlated to the location at surgery. True positive will be defined as an adenoma on imaging in the same location as seen at surgery. Sensitivity will be reported by individual reader.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biochemically proven hyperparathyroidism and an indication for surgery
  • Age ≥ 13 years
  • Karnofsky performance status of > 50 (or ECOG/WHO equivalent).
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
  • Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
  • Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03764007

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Contact: Daniel Thompson

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United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Thomas Hope, MD   
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Insoo Soo, MD University of California, San Francisco
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Responsible Party: Insoo Suh, MD, Principal Investigator, University of California, San Francisco Identifier: NCT03764007    
Other Study ID Numbers: 16-19297
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Insoo Suh, MD, University of California, San Francisco:
Positron emission tomography
Additional relevant MeSH terms:
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Parathyroid Neoplasms
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms