Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04392960
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04392960
Study Brief:
Protocol Section:
NCT04392960