Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04392960|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|AL Amyloidosis||Drug: [18F]Florbetaben||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 22, 2020|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2023|
|Experimental: 18F-florbetaben PET-CT scans||
Patients will undergo on the same day:
All the patients will undergo those evaluations at baseline and 6 months after treatment initiation.
- Evaluation of the prognostic relevance of advanced imaging variables. [ Time Frame: 12 months after diagnosis ]- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
- Evaluation of the prognostic relevance of advanced imaging variables. [ Time Frame: 12 months after diagnosis ]- 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. [ Time Frame: 12 months after diagnosis ]- for F-PET: myocardial uptake score.
- Evaluation of advanced imaging variables in response assessment. [ Time Frame: 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392960
|Contact: Giovanni Palladini, MD, PhDemail@example.com|
|Contact: Anna Carnevale Baragliafirstname.lastname@example.org|
|Fondazione IRCCS Policlinico San Matteo||Recruiting|
|Pavia, Italy, 27100|
|Contact: Giovanni Palladini|