An interventional study of [F-18]-FCH PET/MRI in 18F-fluorocholine, Positron-Emission Tomography and Hyperparathyroidism, Primary, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic
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
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's enrollment of 47 is below the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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.
Also known as: FCH PET/MRI, Fluorine-18 fluorocholine PET/MRI
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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Jun 2021, 38 months.
Of 20 interventional studies with no phase under Hyperparathyroidism, Primary, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 84. This study's 38 months is close to that.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Primary →
University Health Network, Toronto →