18F-fluorocholine PET/CT for Hyperparathyroidism (NCT04316845) | Clinical Trial Compass
CompletedNot Applicable
18F-fluorocholine PET/CT for Hyperparathyroidism
Taiwan38 participantsStarted 2018-01-16
Plain-language summary
Hyperparathyroidism is a common endocrine disorder which can result in many severe complications. For patients with hyperparathyroidism, Tc-99m sestamibi imaging is the major imaging tool for pre-operative localization of the hyperfunctioning gland. However, sestamibi scan have only limited sensitivity in detecting multigland disease and hyperplastic foci. New imaging tracer with 18F-fluorocholine (18F-FCH) has showed avidity in parathyroid tissues. Nevertheless, the research data of 18F-FCH PET/CT are only preliminary.
The goal of our study is to compare the diagnostic performance of 18F-FCH PET/CT and single isotope dual phase sestamibi scintigraphy for patients with hyperparathyroidism.
From Jan. 1st, 2018 till Dec. 31st, 2019, the investigators will prospectively enroll patients with biochemical evidence of hyperparathyroidism and intended to receive pre-operative image study. The patients will receive single isotope dual phase sestamibi scintigraphy and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for hyperfunctioning parathyroid gland. The reference standard will be the final surgical results. Diagnostic performance of both sestamibi scan and PET/CT scan will be measured and calculated.
Who can participate
Age range
20 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients are diagnosed to have hyperparathyroidism based on serum iPTH data (\> 72 pg/mL).
. Planned to undergo surgical resection of the hyperfunctioning parathyroid gland.
. Referred for single isotope dual phase Tc-99m sestamibi scintigraphy.
. The 18F-FCH PET is performed within 6 weeks of the single isotope dual phase Tc-99m sestamibi scintigraphy.
. If premenopausal and sexually active woman, need contraception (tubal ligation, intrauterine devices, or oral contracepts/condom after the last menstrual period till the image exams)
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The sensitivities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
Timeframe: 6 weeks
2
The specificities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
Timeframe: 6 weeks
3
The accuracies of 18F-fluorocholine PET/CT and 99mTc sestamibi scan