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

• Sponsor: CHU de Reims (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03605472
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism	Other: cervical ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
• Actual Study Start Date: Oct 5, 2017
• Anticipated Primary Completion Date: Oct 5, 2019
• Anticipated Study Completion Date: Mar 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients	Other: cervical ultrasound; cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound

Outcome Measures

Primary Outcome Measures

1. Adenoma parathyroid diagnosed using cervical ultrasound [Day 0]

   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

2. Adenoma parathyroid diagnosed using echoscintigraphy [Day 0]

   Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound

3. Adenoma parathyroid diagnosed using anatomopathology [Day 0]

   Adenoma parathyroid diagnosed by anatomopathologist, after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damien JOLLY	Reims		France

Sponsors and Collaborators

• CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT03605472
• Other Study ID Numbers: PA17094
• First Posted: Jul 30, 2018
• Last Update Posted: Jul 30, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by CHU de Reims: primary hyperparathyroidism; cervical ultrasound; echoscintigraphy
• Additional relevant MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary

Study Results

No Results Posted as of Jul 30, 2018