FCH PET/MRI Parathyroid Localization

December 6, 2023 updated by: University Health Network, Toronto

18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas

A prospective trial comparing the accuracy of [F-18]-FCH PET/MRI to US and 99mTc-MIBI SPECT/CT for pre-operative parathyroid localization in patients with primary hyperparathyroidism

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ont
      • Toronto, Ont, Canada, m5g 2c4
        • UHN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Biochemically proven primary hyperparathyroidism
  • Indication for parathyroidectomy as per institutional guidelines

Exclusion Criteria:

  • Contraindication for MRI as per current institutional guidelines.
  • Contraindication for Gadolinium injection as per current institutional guidelines.
  • Renal failure
  • Inability to lie supine for at least 45 minutes.
  • Any participant who is pregnant or breastfeeding.
  • Participants receiving erythropoietin (i.e. for hemochromatosis; might lead to false negative results due to stimulation of bone marrow metabolism)
  • Familial HPT syndromes
  • Participant currently being treated with any cytotoxic chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [F18]-FCH PET/MRI
Patients with primary hyperparathyroidism planned for parathyroidectomy
Diagnostic test: [F-18]-FCH PET/MRI
Subjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.
Other Names:
  • FCH PET/MRI
  • Fluorine-18 fluorocholine PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland
Time Frame: 1 month postoperatively

Value of [F-18]-FCH PET/MRI next to Ultrasound of the Neck and 99mTc-MIBI SPECT/CT in determining which of the four parathyroid glands

Reference standards:

  • Intra-operative location of the hyper functioning gland by inspection and post-operative pathological confirmation.
  • Determination of biochemical cure per usual standard of care: intraoperative PTH and calcium and PTH postoperatively.
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2018

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-5153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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