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Completed

NCT Number: NCT04895631

18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas

This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

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Key information

Conditions

Hyperparathyroidism, Primary Endocrine System Diseases Hyperparathyroidism Parathyroid Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94107, United States

About this study

PRIMARY OBJECTIVE:

I. To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.

OUTLINE:

Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 13 years.
  • Biochemically proven hyperparathyroidism and an indication for surgery.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

  • Current Pregnancy.
  • Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Treatment and study plan

18F-Fluorocholine

Drug

One-time injection of 4-7 millicurie (mCi)

Other names: Fluorocholine

Positron Emission Tomography (PET)

Procedure

Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities

Other names: PET

Primary outcomes

  1. Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging

    Time frame: Up to 1 year

    Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology as compared to sestamibi imaging. 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.

  2. Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold

    Time frame: Up to 1 year

    Sensitivity of 18F-fluorocholine PET for the detection of abnormal parathyroid adenomas confirmed by pathology compared to a predefined threshold. 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.

Secondary outcomes

  1. Detection rate of 18F-fluorocholine PET

    Time frame: Up to 1 year

    The detection rate of 18F-fluorocholine PET in participants who have not undergone surgical resection will be reported

Sponsors and collaborators

Lead sponsor

Thomas Hope

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 20, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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