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

NCT ID: NCT04849754

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with transthyretin related cardiac amyloidosis

Bone scintigraphy

Group Type OTHER

bone scintigraphy

Intervention Type DIAGNOSTIC_TEST

Bone scintigraphy

Interventions

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bone scintigraphy

Bone scintigraphy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fredric MOUQUET

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Le Bois

Locations

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Hôpital privé Le Bois

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frederic MOUQUET

Role: CONTACT

0642377375

Facility Contacts

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Frederic Mouquet

Role: primary

0642377375

Other Identifiers

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2020-A01795-34

Identifier Type: -

Identifier Source: org_study_id

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