Interest of the F18-choline as a Second Line of the Tracer for Detection of Parathyroid Adenomas

Phase 2

Completed

• Conditions: Hyperparathyroidism
• Interventions: Radiation: F18-choline PET examination

• Registration Number: NCT02432599
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

The rationale for the proposed pilot study is to investigate the ability of PET-CT with F18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory MIBI (Tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-04
• Status Verified: 2016-08
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patient aged 18 years or more;
• Patient with a primary hyperparathyroidism and witj a negative or non-contriburatory MIBI parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned;
• Confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests
• Affiliate to a social security system;
• Patient written informed consent.

Exclusion Criteria

• Patient deprived of liberty, under guardianship;
• Any medical or psychological condition witch could compromise the capacity of the patient to participate in the study;
• Pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F18-choline PET	F18-choline PET examination	F18-choline PET examination will be performed before surgery

Primary Outcome Measures

Name	Time	Method
Sensitivity (ability to identify and visualize the parathyroid adenoma)	Up to 2 months	Sensitivity of PET-CT with F18-choline (FCH) to identify and visualize the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory parathyroid scintigraphy MIBI and cervical ultrasound

Trial Locations

Locations (2)

CHU; 🇫🇷 Caen, France

Centre François Baclesse; 🇫🇷 Caen, France