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FCH PET/MRI Parathyroid Localization

Sponsor
University Health Network, Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT03324893
Collaborator
(none)
47
Enrollment
1
Location
1
Arm
38.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: [F-18]-FCH PET/MRI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas
Actual Study Start Date :
Apr 3, 2018
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHN Toronto Ont Canada m5g 2c4

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03324893
    Other Study ID Numbers:
    • 16-5153
    First Posted:
    Oct 30, 2017
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Hyperparathyroidism
    Hyperparathyroidism, Primary

    Study Results

    No Results Posted as of Aug 13, 2020