NCT03324893

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 3, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2021

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

October 17, 2017

Last Update Submit

December 6, 2023

Conditions

18F-fluorocholinePositron-Emission TomographyHyperparathyroidism, Primary

Outcome Measures

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.

    1 month postoperatively

Study Arms (1)

[F18]-FCH PET/MRI

EXPERIMENTAL

Patients with primary hyperparathyroidism planned for parathyroidectomy

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

Interventions

[F-18]-FCH PET/MRIDIAGNOSTIC_TEST

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
[F18]-FCH PET/MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHN

Toronto, Ontario, m5g 2c4, Canada

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 30, 2017

Study Start

April 3, 2018

Primary Completion

June 23, 2021

Study Completion

June 23, 2021

Last Updated

December 7, 2023

Record last verified: 2023-12

Locations

CA(1)