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

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ClinicalTrials.gov Identifier: NCT03605472
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date  ICMJE July 20, 2018
First Posted Date  ICMJE July 30, 2018
Last Update Posted Date July 30, 2018
Actual Study Start Date  ICMJE October 5, 2017
Estimated Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Adenoma parathyroid diagnosed using cervical ultrasound [ Time Frame: 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
  • Adenoma parathyroid diagnosed using echoscintigraphy [ Time Frame: Day 0 ]
    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 [ Time Frame: Day 0 ]
    Adenoma parathyroid diagnosed by anatomopathologist, after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
Official Title  ICMJE Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Hyperparathyroidism
Intervention  ICMJE Other: cervical ultrasound
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound
Study Arms  ICMJE Experimental: Patients
Intervention: Other: cervical ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 5, 2020
Estimated Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brigitte DELEMER 0326788101 bdelemer@chu-reims.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03605472
Other Study ID Numbers  ICMJE PA17094
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHU de Reims
Study Sponsor  ICMJE CHU de Reims
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHU de Reims
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP