FCH PET/MRI Parathyroid Localization

Positron-Emission Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324893
• Other study ID #: 16-5153
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: June 23, 2021

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 18F-fluorocholine
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Positron-Emission Tomography

Intervention

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

Locations

Country	Name	City	State
Canada	UHN	Toronto	Ont

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month postoperatively