Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03605472
Other study ID # PA17094
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2017
Est. completion date March 5, 2020

Study information

Verified date July 2018
Source CHU de Reims
Contact Brigitte DELEMER
Phone 0326788101
Email bdelemer@chu-reims.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 5, 2020
Est. primary completion date October 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
cervical ultrasound
cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Adenoma parathyroid diagnosed using anatomopathology Adenoma parathyroid diagnosed by anatomopathologist, after surgery. Day 0
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931109 - Circulating miRNA in Primary Hyperparathyroidism
Completed NCT04305561 - Preoperative Localization Strategies in Primary Hyperparathyroidism N/A
Recruiting NCT03052075 - Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Completed NCT03774771 - Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism Phase 2
Recruiting NCT02854345 - Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera N/A
Completed NCT01222026 - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate Phase 4
Recruiting NCT00973336 - Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery? Phase 2
Completed NCT01530919 - Minimally Invasive Radioguided Parathyroidectomy N/A
Completed NCT01306656 - Vitamin D Repletion in Primary Hyperparathyroidism Phase 4
Terminated NCT00961701 - Lipids Profile in Primary Hyperparathyroidism N/A
Completed NCT00432939 - Primary Hyperparathyroidism: Non-classical Manifestations N/A
Completed NCT00522028 - Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial N/A
Completed NCT03713671 - Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism N/A
Recruiting NCT04969926 - Natural History Study of Parathyroid Disorders
Recruiting NCT03039439 - Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
Not yet recruiting NCT03732157 - Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients
Completed NCT01996072 - EC17 for Intraoperative Imaging for Parathyroidectomy Phase 1
Completed NCT01460030 - An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism Phase 3
Enrolling by invitation NCT04085419 - Osteoporosis in Primary Hyperparathyroidism Phase 4
Recruiting NCT03935984 - Calcitonin Pre-treatment to Improve SPECT-CT Sensitivity Phase 4