Hyperparathyroidism Clinical Trial
— APACH2Official title:
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
Verified date | July 2023 |
Source | Centre Francois Baclesse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | June 30, 2023 |
Est. primary completion date | May 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | CHU Brest | Brest | |
France | Centre François Baclesse | Caen | |
France | Centre Eugène Marquis | Rennes | |
France | CHU | Rennes |
Lead Sponsor | Collaborator |
---|---|
Centre Francois Baclesse | Fondation de l'Avenir |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity | Up to 2 months | ||
Secondary | Evaluate post-surgical complications by measuring tne number of infections, hematoma | Up to 2 months |
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