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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Recruiting
CT.gov ID
NCT04849754
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
48.1
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: bone scintigraphy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Feb 25, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with transthyretin related cardiac amyloidosis

Bone scintigraphy

Diagnostic Test: bone scintigraphy
Bone scintigraphy

Outcome Measures

Primary Outcome Measures

  1. Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital privé Le Bois Lille France 59000

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Fredric MOUQUET, Hôpital Privé Le Bois

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT04849754
Other Study ID Numbers:
  • 2020-A01795-34
First Posted:
Apr 19, 2021
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Amyloidosis

Study Results

No Results Posted as of Apr 26, 2021