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

Study Overview
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Brief Summary
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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.

Official Title
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Phase III 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

Conditions
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F18-choline, Parathyroid Adenoma, Hyperparathyroidism

Intervention / Treatment
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* Diagnostic Test: MIBI scintigraphy
* Diagnostic Test: F18-choline PET


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open, randomized, phase III study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TEMP-TDM with MIBI<br>Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET | Diagnostic Test: MIBI scintigraphy<br>* Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET<br>* Other names: F18-choline PET;Diagnostic Test: F18-choline PET<br>* Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy<br>* Other names: MIBI scintigraphy;|
| Other: F18-choline PET<br>Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy | Diagnostic Test: MIBI scintigraphy<br>* Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET<br>* Other names: F18-choline PET;Diagnostic Test: F18-choline PET<br>* Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy<br>* Other names: MIBI scintigraphy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely |  | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity |  | Up to 2 months | 
| Evaluate post-surgical complications by measuring tne number of infections, hematoma |  | Up to 2 months |