18F-fluorocholine, Hyperparathyroidism, Primary, Positron-Emission Tomography
Conditions
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
Interventions
DIAGNOSTIC_TEST[F-18]-FCH PET/MRI
Subjects will undergo the \[F-18\]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed