Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
Not Applicable
Recruiting
- Conditions
- AL Amyloidosis
- Interventions
- Drug: [18F]Florbetaben
- Registration Number
- NCT04392960
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 69
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-florbetaben PET-CT scans [18F]Florbetaben -
- Primary Outcome Measures
Name Time Method Evaluation of the prognostic relevance of advanced imaging variables. 12 months after diagnosis - for F-PET: myocardial uptake score.
Evaluation of advanced imaging variables in response assessment. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy