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

Centre Francois Baclesse2 sites in 1 country28 target enrollmentMarch 2015

ConditionsHyperparathyroidism

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hyperparathyroidism
Sponsor: Centre Francois Baclesse
Enrollment: 28
Locations: 2
Primary Endpoint: Sensitivity (ability to identify and visualize the parathyroid adenoma)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

February 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Francois Baclesse

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensitivity (ability to identify and visualize the parathyroid adenoma)

Time Frame: 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