Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
ECHOPARAT
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2017
CompletedFirst Submitted
Initial submission to the registry
July 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedJuly 30, 2018
July 1, 2018
2 years
July 20, 2018
July 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Adenoma parathyroid diagnosed using anatomopathology
Adenoma parathyroid diagnosed by anatomopathologist, after surgery.
Day 0
Study Arms (1)
Patients
EXPERIMENTALInterventions
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound
Eligibility Criteria
You may qualify if:
- Patients with primary hyperparathyroidism with surgery indication
- Age \> 18yo
You may not qualify if:
- surgical contraindication
- medical treatment by cinacalcet
- non sporadic hyperparathyroidism
- Age \<18yo
- Protected by the law
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Damien JOLLY
Reims, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2018
First Posted
July 30, 2018
Study Start
October 5, 2017
Primary Completion
October 5, 2019
Study Completion
March 5, 2020
Last Updated
July 30, 2018
Record last verified: 2018-07