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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Cardiac Amyloidosis

Treatments: Diagnostic Test: bone scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT04849754

2020-A01795-34

Details and patient eligibility

About

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 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients with transthyretin related cardiac amyloidosis

Other group

Description:

Bone scintigraphy

Treatment:

Diagnostic Test: bone scintigraphy