Phase III trial comparing 2 diagnostic strategies for the preoperative localization of parathyroid adenoma in primary hyperparathyroidism:TEMP / CT with Tc99m-sestaMIBI or PET / CT with F18-choline in first intentio

Phase 1

• Conditions: Patient with primary hyperparathyroidism and for which surgical resection is provided.; MedDRA version: 20.0Level: PTClassification code 10020705Term: HyperparathyroidismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-000274-36-FR
• Lead Sponsor: Centre François Baclesse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-02
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

- Patient over 18 years of age
- Patient with primary hyperparathyroidism for whom excisional surgery is planned
- Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations)
- Affiliation to a social security system
- Patient who has signed his written consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58

Exclusion Criteria

- Patient deprived of liberty, under guardianship 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 breastfeeding woman
- History of parathyroid surgery
- Patient with Multiple Endocrine Neoplasia 1 (MEN1)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified