Clinical trial NCT04392960: 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
Overall status: RECRUITING
Phase: NA
Conditions: AL Amyloidosis
Keywords: Amyloidosis
Prognosis
[18F]Florbetaben
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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;

Primary outcomes:
measure: Evaluation of the prognostic relevance of advanced imaging variables.
timeFrame: 12 months after diagnosis
measure: Evaluation of the prognostic relevance of advanced imaging variables.
timeFrame: 12 months after diagnosis
measure: Evaluation of the prognostic relevance of advanced imaging variables.
timeFrame: 12 months after diagnosis
measure: Evaluation of advanced imaging variables in response assessment.
timeFrame: 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
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