Back to resultsFCH PET/MRI Parathyroid Localization
Primary Purpose
18F-fluorocholine, Positron-Emission Tomography, Hyperparathyroidism, Primary
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
[F-18]-FCH PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for 18F-fluorocholine
Eligibility Criteria
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
Sites / Locations
- UHN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[F18]-FCH PET/MRI
Arm Description
Patients with primary hyperparathyroidism planned for parathyroidectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03324893
First Posted
October 17, 2017
Last Updated
December 9, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03324893
Brief Title
FCH PET/MRI Parathyroid Localization
Official Title
18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
18F-fluorocholine, Positron-Emission Tomography, Hyperparathyroidism, Primary
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[F18]-FCH PET/MRI
Arm Type
Experimental
Arm Description
Patients with primary hyperparathyroidism planned for parathyroidectomy
Intervention Type
Diagnostic Test
Intervention Name(s)
[F-18]-FCH PET/MRI
Other Intervention Name(s)
FCH PET/MRI, Fluorine-18 fluorocholine PET/MRI
Intervention Description
Subjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.
Primary Outcome Measure Information:
Title
Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UHN
City
Toronto
State/Province
Ont
ZIP/Postal Code
m5g 2c4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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FCH PET/MRI Parathyroid Localization
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