Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy (QUANTI-SUV)
Primary Purpose
Cardiac Amyloidosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bone scintigraphy
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Amyloidosis
Eligibility Criteria
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
Sites / Locations
- Hôpital privé Le BoisRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with transthyretin related cardiac amyloidosis
Arm Description
Bone scintigraphy
Outcomes
Primary Outcome Measures
Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
Secondary Outcome Measures
Full Information
NCT ID
NCT04849754
First Posted
April 15, 2021
Last Updated
April 22, 2021
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT04849754
Brief Title
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with transthyretin related cardiac amyloidosis
Arm Type
Other
Arm Description
Bone scintigraphy
Intervention Type
Diagnostic Test
Intervention Name(s)
bone scintigraphy
Intervention Description
Bone scintigraphy
Primary Outcome Measure Information:
Title
Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic MOUQUET
Phone
0642377375
Email
fmouquet@ovh.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredric MOUQUET
Organizational Affiliation
Hôpital Privé Le Bois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital privé Le Bois
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Mouquet
Phone
0642377375
Email
fmouquet@ovh.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy
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