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

Cardiac Amyloidosis Clinical Trial

— QUANTI-SUV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849754
• Other study ID #: 2020-A01795-34
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Frederic MOUQUET
• Phone: 0642377375
• Email: fmouquet[@]ovh.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Diagnostic Test:
• bone scintigraphy
Bone scintigraphy

Locations

Country	Name	City	State
France	Hôpital privé Le Bois	Lille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy		6 months