18F-fluorocholineNCT03324893
FCH PET/MRI Parathyroid Localization
A study testing [F-18]-FCH PET/MRI in people with 18F-fluorocholine and Positron-Emission Tomography, run by University Health Network, Toronto at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 18F-fluorocholine, Positron-Emission Tomography, Hyperparathyroidism, Primary
- What is being tested?
- [F-18]-FCH PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2018to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Biochemically proven primary hyperparathyroidism
- Indication for parathyroidectomy as per institutional guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas
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
- Being tested
- [F-18]-FCH PET/MRI
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]-FCH PET/MRIDiagnostic test
Also called FCH PET/MRI, Fluorine-18 fluorocholine PET/MRI
Subjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.
| Study group | Role | What they receive |
|---|---|---|
| [F18]-FCH PET/MRI | Experimental | Patients with primary hyperparathyroidism planned for parathyroidectomy Receives: Diagnostic Test: [F-18]-FCH PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start3 Apr 2018
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18F-fluorocholineStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324893
- Sponsor's protocol ID
- 16-5153
- Status last verified
- Dec 2023
- First submitted
- 17 Oct 2017
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluorocholine PET/MRI for the Localization of Parathyroid Adenomas
- ClinicalTrials.gov ID
- NCT03324893
- Acronym / sponsor ID
- 16-5153
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F18]-FCH PET/MRI | Experimental | Diagnostic Test: [F-18]-FCH PET/MRIPatients with primary hyperparathyroidism planned for parathyroidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Biochemically proven primary hyperparathyroidism
- Indication for parathyroidectomy as per institutional guidelines
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]-FCH PET/MRIAlso: FCH PET/MRI, Fluorine-18 fluorocholine PET/MRISubjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy. | Diagnostic test | [F18]-FCH PET/MRI |
Primary outcome
Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [F-18]-FCH PET/MRI in people with 18F-fluorocholine and Positron-Emission Tomography, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland (time frame: 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.