FCH PET/MRI Parathyroid Localization

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

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Key information

Conditions

18F-fluorocholine Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases Positron-Emission Tomography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHN

Toronto, Ontario, m5g 2c4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[F-18]-FCH PET/MRI

Diagnostic Test

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Oct 30, 2017
Registry last updated: Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed