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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 : Unknown
Verified July 2018 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 5, 2017
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients Other: cervical ultrasound
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. Adenoma parathyroid diagnosed using anatomopathology [ Time Frame: Day 0 ]
    Adenoma parathyroid diagnosed by anatomopathologist, after surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605472


Contacts
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Contact: Brigitte DELEMER 0326788101 bdelemer@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Brigitte DELEMER    0326788101 ext 0033    bdelemer@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03605472    
Other Study ID Numbers: PA17094
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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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:
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Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases