Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy

Overview

Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Full Title of Study: “Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy for the Follow-up of Patients With Transthyretin Amyloidosis Treated With Tafamidis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2023

Detailed Description

Cardiac amyloidosis is a cause of restrictive cardiomyopathy with preserved ejection fraction associated with amyloid fibrils deposits in the myocardium. Two types of amyloid commonly infiltrate the heart: immunoglobulin light-chain amyloid (AL), and transthyretin-related amyloid amyloidosis (ATTR). Cardiac imaging is currently used for the diagnosis of ATTR, including planar scintigraphy with bone seeking radiopharmaceuticals, cardiac magnetic resonance and echocardiography with global longitudinal strain assessment.Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Interventions

  • Diagnostic Test: bone scintigraphy
    • Bone scintigraphy

Arms, Groups and Cohorts

  • Other: Patients with transthyretin related cardiac amyloidosis
    • Bone scintigraphy

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patient, male or female, over 18 years of age – Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy – Patient with signed consent Exclusion Criteria:

  • Patients with systemic AL amyloidosis – Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision – Pregnant or breastfeeding woman

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GCS Ramsay Santé pour l’Enseignement et la Recherche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fredric MOUQUET, Principal Investigator, Hôpital Privé Le Bois
  • Overall Contact(s)
    • Frederic MOUQUET, 0642377375, fmouquet@ovh.fr

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