New imaging techniques for patients with cardiac AL amyloidosis
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
This study is testing new imaging techniques to see how well they can help doctors monitor and understand the condition in people who have just been diagnosed with cardiac AL amyloidosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia) |
| Trial ID | NCT04392960 on ClinicalTrials.gov |
What this trial studies
This study evaluates novel imaging tools, including echocardiography, cardiac magnetic resonance (CMR), and positron emission tomography (PET) using [18F]Florbetaben, in patients newly diagnosed with cardiac AL amyloidosis. The assessment will occur at baseline and after treatment to determine the effectiveness of these imaging modalities in monitoring the disease. The study aims to provide a systematic approach to understanding the prognosis and treatment response in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a histological diagnosis of AL amyloidosis and measurable cardiac involvement.
Not a fit: Patients with non-AL amyloidosis or those in NYHA class IV heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and monitoring cardiac AL amyloidosis, leading to better treatment outcomes for patients.
How similar studies have performed: While novel, the use of advanced imaging techniques in similar conditions has shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Palladini, MD, PhD
- Email: segreteria.amiloidosi@smatteo.pv.it
- Phone: +390382502994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.