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CompletedNCT03324893Updated Dec 7, 2023

FCH PET/MRI Parathyroid Localization

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

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • 18F-fluorocholine
  • Positron-Emission Tomography
  • Hyperparathyroidism, Primary
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years
  • Biochemically proven primary hyperparathyroidism
  • Indication for parathyroidectomy as per institutional guidelines

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    [F18]-FCH PET/MRI

    Patients with primary hyperparathyroidism planned for parathyroidectomy

    Diagnostic Test: [F-18]-FCH PET/MRI

Interventions

  • 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

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • UHN
    Toronto, Ont m5g 2c4, Canada
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03324893
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Oct 30, 2017
Start date
Apr 3, 2018
Primary completion
Jun 23, 2021
Completion
Jun 23, 2021
Last update
Dec 7, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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