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

Phase 3

Completed

• Conditions: Parathyroid Adenoma; Hyperparathyroidism; F18-choline
• Interventions: Diagnostic Test: MIBI scintigraphy; Diagnostic Test: F18-choline PET

• Registration Number: NCT04040946
• Lead Sponsor: Centre Francois Baclesse

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 positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Study Start: 2019-09-19
• Primary Completion: 2022-05-05
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F18-choline PET	F18-choline PET	Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
TEMP-TDM with MIBI	F18-choline PET	Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET
F18-choline PET	MIBI scintigraphy	Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
TEMP-TDM with MIBI	MIBI scintigraphy	Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluate post-surgical complications by measuring tne number of infections, hematoma	Up to 2 months
Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity	Up to 2 months

Trial Locations

Locations (4)

CHU Brest; 🇫🇷 Brest, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

CHU; 🇫🇷 Rennes, France