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Diagnostic Accuracy of 3T MR for Secondary Hyperparathyroidism Comparison With 4DCT

Sponsor
Fifth Affiliated Hospital, Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05540795
Collaborator
(none)
100
Enrollment
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Parathyroidectomy for patients with drug-refractory SHPT is recommended in the clinical practice guidelines of the Global Organization for Improving Prognosis in Kidney Disease (KDIGO) and the Japanese Dialysis Therapy Society (JSDT) . Therefore, accurate localization and detection of parathyroid abnormalities is the key to avoid persistent recurrence of the disease. However, the sensitivity and specificity of the existing ultrasound and 99MTC-MIBI diagnosis are limited. CT examination is radiative and requires iodine contrast medium with nephrotoxicity, which may require timely dialysis and long-term monitoring for hemodialysis patients. 3T MRI has no radiation and does not need to use iodine contrast agent, which can well detect parathyroid lesions . Previous studies have reported that 3T MRI can diagnose primary hyperparathyroidism (PHPT), but the diagnostic efficacy of SHPT is still unclear. Therefore, this study aims to evaluate the preoperative diagnostic value of non-enhanced 3T MRI compared with 4DCT in patients with secondary hyperparathyroidism after hemodialysis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Diagnostic Accuracy of 3T Unenhanced MR Imaging for the Detection of Parathyroid Lesions Before Surgery in Hemodialysis Patients With Secondary Hyperparathyroidism Comparison With 4DCT
    Anticipated Study Start Date :
    Sep 20, 2022
    Anticipated Primary Completion Date :
    Oct 20, 2022
    Anticipated Study Completion Date :
    Dec 20, 2022

    Outcome Measures

    Primary Outcome Measures

    1. sensitivity [1month]

      The number of positive tests as a percentage of the total number of cases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. undergoing total parathyroidectomy with severe SHPT, and 2) undergoing 4DCT and routine unenhanced MRI.
    Exclusion Criteria:
    • Patients were excluded if they had known contraindications to MR or CT imaging. Patients were also excluded if their images could not be used for diagnosis due to quality.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fifth Affiliated Hospital, Sun Yat-Sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ying Wang, Director, Fifth Affiliated Hospital, Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05540795
    Other Study ID Numbers:
    • ZDWY.HYXK.006
    First Posted:
    Sep 15, 2022
    Last Update Posted:
    Sep 19, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Hyperparathyroidism
    Hyperparathyroidism, Secondary
    Parathyroid Diseases

    Study Results

    No Results Posted as of Sep 19, 2022