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NCT Number: NCT04849754

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bone scintigraphy

Diagnostic Test

Bone scintigraphy

Primary outcomes

  1. Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Frederic MOUQUET

CONTACT

[email protected]

0642377375

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study 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

Acronym: QUANTI-SUV

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2021
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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