Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism

Primary Hyperparathyroidism Clinical Trial

— ECHOPARAT  

Official title:

Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605472
• Other study ID #: PA17094
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: March 5, 2020

Study information

• Verified date: July 2018
• Source: CHU de Reims
• Contact: Brigitte DELEMER
• Phone: 0326788101
• Email: bdelemer[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).

This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.

The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).

However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 5, 2020
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with primary hyperparathyroidism with surgery indication

• Age > 18yo

Exclusion Criteria:

• surgical contraindication

• medical treatment by cinacalcet

• non sporadic hyperparathyroidism

• Age <18yo

• Protected by the law

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

Other:
• cervical ultrasound
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma parathyroid diagnosed using cervical ultrasound	Adenoma parathyroid diagnosed using cervical ultrasound. Cervical ultrasound will be realized by a endocrinologist trained in the cervical ultrasound and not informed of the results of the echoscintigraphy	Day 0
Primary	Adenoma parathyroid diagnosed using echoscintigraphy	Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound	Day 0
Primary	Adenoma parathyroid diagnosed using anatomopathology	Adenoma parathyroid diagnosed by anatomopathologist, after surgery.	Day 0