Status:
COMPLETED
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
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
Fondation de l'Avenir
Conditions:
Parathyroid Adenoma
Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04040946
Start Date
September 19 2019
End Date
June 30 2023
Last Update
August 1 2023
Active Locations (4)
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1
CHU Brest
Brest, France
2
Centre François Baclesse
Caen, France, 14076
3
Centre Eugène Marquis
Rennes, France
4
CHU
Rennes, France