FCH PET/MRI Parathyroid Localization

University Health Network, Toronto47 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

18F-fluorocholine Positron-Emission Tomography Hyperparathyroidism, Primary

Interventions

[F-18]-FCH PET/MRIDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UHN

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

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.

Time frame: 1 month postoperatively

Data from ClinicalTrials.gov

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