CompletedPhase 3

Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention

France59 participantsStarted 2019-09-19

Plain-language summary

The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.

Who can participate

Age range

18 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: * Patient 18 years old * Patient presenting with primary hyperparathyroidism and for whom an excisional surgery is planned * For women of childbearing age, negative pregnancy test at Baseline * Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations) * Affiliation to a social security scheme * Patient having signed his written consent Exclusion Criteria: * Patient deprived of liberty, under tutorship or curatorship * Hypersensitivity to TECNESCAN SESTAMIBI * Any associated medical or psychological condition that could compromise the patient's ability to participate in the study * Pregnant or lactating woman * History of parathyroid surgery * Patient with multiple endocrine neoplasia 1 (NEM1) * Known hypersensitivity to fluorocholine or to any of the excipients (sodium chloride, water for injections)

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

Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely

Timeframe: Up to 2 months

Trial details

NCT IDNCT04040946

SponsorCentre Francois Baclesse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-05

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