Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy (QUANTI-SUV)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Diagnostic test: bone scintigraphy

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederic Mouquet; Phone Number: 0642377375; Email: fmouquet@ovh.fr

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Hôpital Privé Le Bois
    • Contact: Frederic Mouquet; Phone Number: 0642377375; Email: fmouquet@ovh.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with transthyretin related cardiac amyloidosis; Bone scintigraphy	Diagnostic test: bone scintigraphy; Bone scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy	6 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Fredric MOUQUET, Hôpital Privé Le Bois

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 2020-A01795-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No