Back to resultsComparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism (ECHOPARAT)
Primary Purpose
Primary Hyperparathyroidism
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cervical ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Hyperparathyroidism focused on measuring primary hyperparathyroidism, cervical ultrasound, echoscintigraphy
Eligibility Criteria
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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
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
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
Adenoma parathyroid diagnosed using anatomopathology
Adenoma parathyroid diagnosed by anatomopathologist, after surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03605472
Brief Title
Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
Acronym
ECHOPARAT
Official Title
Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
October 5, 2019 (Anticipated)
Study Completion Date
March 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
Keywords
primary hyperparathyroidism, cervical ultrasound, echoscintigraphy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
cervical ultrasound
Intervention Description
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound
Primary Outcome Measure Information:
Title
Adenoma parathyroid diagnosed using cervical ultrasound
Description
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
Time Frame
Day 0
Title
Adenoma parathyroid diagnosed using echoscintigraphy
Description
Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound
Time Frame
Day 0
Title
Adenoma parathyroid diagnosed using anatomopathology
Description
Adenoma parathyroid diagnosed by anatomopathologist, after surgery.
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brigitte DELEMER
Phone
0326788101
Email
bdelemer@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte DELEMER
Phone
0326788101
Ext
0033
Email
bdelemer@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
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