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Completed

NCT Number: NCT03764007

18F-Fluorocholine for the Detection of Parathyroid Adenomas

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

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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 2 / Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Biochemically proven hyperparathyroidism and an indication for surgery
  • Age >= 13 years old
  • Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (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.

Treatment and study plan

18F-Fluorocholine

Drug

Given intravenously

Other names: Fluorocholine

Positron Emission Tomography (PET)

Procedure

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

Other names: PET

Primary outcomes

  1. Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma

    Time frame: Up to 1 year

    The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

  2. Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging

    Time frame: Up to 1 year

    The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Secondary outcomes

  1. Detection Rate in Patients Who Have Not Undergone Surgical Resection

    Time frame: Up to 1 year

    The detection rate is defined as the proportion of participants with a 18F-fluorocholine PET positive read who do not subsequently undergo parathyroidectomy, using the dictated reports to determine the detection sensitivity for parathyroid adenomas. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.

Sponsors and collaborators

Lead sponsor

Thomas Hope

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2018
Registry last updated
Oct 19, 2021

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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