FCH PET/MRI Parathyroid Localization

NCT ID: NCT03324893

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-03

Study Completion Date

2021-06-23

Brief Summary

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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

Detailed Description

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Conditions

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18F-fluorocholine Positron-Emission Tomography Hyperparathyroidism, Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[F18]-FCH PET/MRI

Patients with primary hyperparathyroidism planned for parathyroidectomy

Group Type EXPERIMENTAL

[F-18]-FCH PET/MRI

Intervention Type DIAGNOSTIC_TEST

Subjects will undergo the \[F-18\]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.

Interventions

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[F-18]-FCH PET/MRI

Subjects will undergo the \[F-18\]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FCH PET/MRI Fluorine-18 fluorocholine PET/MRI

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UHN

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16-5153

Identifier Type: -

Identifier Source: org_study_id