Back to resultsNovel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
Primary Purpose
AL Amyloidosis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
[18F]Florbetaben
Sponsored by
About this trial
This is an interventional diagnostic trial for AL Amyloidosis focused on measuring Amyloidosis, Prognosis, [18F]Florbetaben
Eligibility Criteria
Inclusion Criteria:
- age more than 18;
- histological diagnosis of AL amyloidosis;
- measurable cardiac involvement as per current response criteria (i.e. NT-proBNP >650 ng/L);
- measurable hematologic disease (dFLC >20 mg/L);
- adequate renal function (eGFR >30 mL/min) in order to be safely administered gadolinium;
- absence of atrial fibrillation with uncontrolled heart rate;
- absence of implantable cardiac devices;
- absence of pulmonary amyloidosis histologically documented;
- plan to start anti-plasma cell chemotherapy;
- plan to assess response at the Pavia center after 6 months;
- have given written informed consent to participate.
Exclusion Criteria:
- non-AL amyloidosis;
- NYHA class IV;
- PS-ECOG >3;
- severe allergy to paramagnetic tracer;
- severe claustrophobia;
- pregnant or nursing women;
Sites / Locations
- Fondazione IRCCS Policlinico San MatteoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-florbetaben PET-CT scans
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of the prognostic relevance of advanced imaging variables.
- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
Evaluation of the prognostic relevance of advanced imaging variables.
- for echocardiography: left ventricular wall thickness (mLVW), EF, 2D-GLS, midwall fractional shortening (mFS), and stroke volume index (SVI);
Evaluation of the prognostic relevance of advanced imaging variables.
- for F-PET: myocardial uptake score.
Evaluation of advanced imaging variables in response assessment.
The same variables considered at baseline will be measured 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone. Changes in these variables compared to baseline will be considered.
Secondary Outcome Measures
Full Information
NCT ID
NCT04392960
First Posted
February 27, 2020
Last Updated
June 5, 2023
Sponsor
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT04392960
Brief Title
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
Official Title
Molecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
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
This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AL Amyloidosis
Keywords
Amyloidosis, Prognosis, [18F]Florbetaben
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-florbetaben PET-CT scans
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F]Florbetaben
Intervention Description
Patients will undergo on the same day:
18F-florbetaben PET-CT scans. The dose to be injected intravenously (6 second/mL) will be 370 MBq (for a 70 Kg patient);
standard assessment of clonal and organ disease;
echocardiography;
cardiac magnetic resonance.
All the patients will undergo those evaluations at baseline and 6 months after treatment initiation.
Primary Outcome Measure Information:
Title
Evaluation of the prognostic relevance of advanced imaging variables.
Description
- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
Time Frame
12 months after diagnosis
Title
Evaluation of the prognostic relevance of advanced imaging variables.
Description
- for echocardiography: left ventricular wall thickness (mLVW), EF, 2D-GLS, midwall fractional shortening (mFS), and stroke volume index (SVI);
Time Frame
12 months after diagnosis
Title
Evaluation of the prognostic relevance of advanced imaging variables.
Description
- for F-PET: myocardial uptake score.
Time Frame
12 months after diagnosis
Title
Evaluation of advanced imaging variables in response assessment.
Description
The same variables considered at baseline will be measured 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone. Changes in these variables compared to baseline will be considered.
Time Frame
6 months after initiation of chemotherapy targeting the amyloid plasma cell clone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18;
histological diagnosis of AL amyloidosis;
measurable cardiac involvement as per current response criteria (i.e. NT-proBNP >650 ng/L);
measurable hematologic disease (dFLC >20 mg/L);
adequate renal function (eGFR >30 mL/min) in order to be safely administered gadolinium;
absence of atrial fibrillation with uncontrolled heart rate;
absence of implantable cardiac devices;
absence of pulmonary amyloidosis histologically documented;
plan to start anti-plasma cell chemotherapy;
plan to assess response at the Pavia center after 6 months;
have given written informed consent to participate.
Exclusion Criteria:
non-AL amyloidosis;
NYHA class IV;
PS-ECOG >3;
severe allergy to paramagnetic tracer;
severe claustrophobia;
pregnant or nursing women;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Palladini, MD, PhD
Phone
+390382502994
Email
segreteria.amiloidosi@smatteo.pv.it
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Carnevale Baraglia
Phone
+390382502994
Email
a.carnevalebaraglia@smatteo.pv.it
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Palladini
12. IPD Sharing Statement
Citations:
PubMed Identifier
20644111
Citation
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Citation
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Citation
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Citation
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Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
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