FCH PET/MRI Parathyroid Localization

Not Applicable

Completed

• Conditions: 18F-fluorocholine; Positron-Emission Tomography; Hyperparathyroidism, Primary
• Interventions: Diagnostic Test: [F-18]-FCH PET/MRI

• Registration Number: NCT03324893
• Lead Sponsor: University Health Network, Toronto

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-30
• Study Start: 2018-04-03
• Primary Completion: 2021-06-23
• Study Completion: 2021-06-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[F18]-FCH PET/MRI	[F-18]-FCH PET/MRI	Patients with primary hyperparathyroidism planned for parathyroidectomy

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UHN; 🇨🇦 Toronto, Ont, Canada