Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis (NCT04392960) | Clinical Trial Compass
CompletedNot Applicable
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
Italy30 participantsStarted 2020-07-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the prognostic relevance of advanced imaging variables.
Timeframe: 12 months after diagnosis
2
Evaluation of the prognostic relevance of advanced imaging variables.
Timeframe: 12 months after diagnosis
3
Evaluation of the prognostic relevance of advanced imaging variables.
Timeframe: 12 months after diagnosis
4
Evaluation of advanced imaging variables in response assessment.
Timeframe: 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone
Trial details
NCT IDNCT04392960
SponsorFondazione IRCCS Policlinico San Matteo di Pavia