Clinical trial · Interventional
Novel Imaging Tools in Newly-diagnosed 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
NCT04392960CI-TRIAL-00108520completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AL Amyloidosis | AL Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]Florbetaben | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-florbetaben PET-CT scans
- interventionNames
- Drug: [18F]Florbetaben
Primary outcomes (4)
- measure
- Evaluation of the prognostic relevance of advanced imaging variables.
- timeFrame
- 12 months after diagnosis
- description
- \- for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);
- measure
- Evaluation of the prognostic relevance of advanced imaging variables.
- timeFrame
- 12 months after diagnosis
- description
- \- for echocardiography: left ventricular wall thickness (mLVW), EF, 2D-GLS, midwall fractional shortening (mFS), and stroke volume index (SVI);
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (10)
- BACKGROUNDPalladini G, Barassi A, Klersy C, Pacciolla R, Milani P, Sarais G, Perlini S, Albertini R, Russo P, Foli A, Bragotti LZ, Obici L, Moratti R, Melzi d'Eril GV, Merlini G. The combination of high-sensitivity cardiac troponin T (hs-cTnT) at presentation and changes in N-terminal natriuretic peptide type B (NT-proBNP) after chemotherapy best predicts survival in AL amyloidosis. Blood. 2010 Nov 4;116(18):3426-30. doi: 10.1182/blood-2010-05-286567. Epub 2010 Jul 19. PMID 20644111
- BACKGROUNDDispenzieri A, Gertz MA, Kyle RA, Lacy MQ, Burritt MF, Therneau TM, Greipp PR, Witzig TE, Lust JA, Rajkumar SV, Fonseca R, Zeldenrust SR, McGregor CG, Jaffe AS. Serum cardiac troponins and N-terminal pro-brain natriuretic peptide: a staging system for primary systemic amyloidosis. J Clin Oncol. 2004 Sep 15;22(18):3751-7. doi: 10.1200/JCO.2004.03.029. PMID 15365071
- BACKGROUNDWechalekar AD, Schonland SO, Kastritis E, Gillmore JD, Dimopoulos MA, Lane T, Foli A, Foard D, Milani P, Rannigan L, Hegenbart U, Hawkins PN, Merlini G, Palladini G. A European collaborative study of treatment outcomes in 346 patients with cardiac stage III AL amyloidosis. Blood. 2013 Apr 25;121(17):3420-7. doi: 10.1182/blood-2012-12-473066. Epub 2013 Mar 11. PMID 23479568
- BACKGROUNDPalladini G, Lavatelli F, Russo P, Perlini S, Perfetti V, Bosoni T, Obici L, Bradwell AR, D'Eril GM, Fogari R, Moratti R, Merlini G. Circulating amyloidogenic free light chains and serum N-terminal natriuretic peptide type B decrease simultaneously in association with improvement of survival in AL. Blood. 2006 May 15;107(10):3854-8. doi: 10.1182/blood-2005-11-4385. Epub 2006 Jan 24. PMID 16434487
- BACKGROUNDPalladini G, Dispenzieri A, Gertz MA, Kumar S, Wechalekar A, Hawkins PN, Schonland S, Hegenbart U, Comenzo R, Kastritis E, Dimopoulos MA, Jaccard A, Klersy C, Merlini G. New criteria for response to treatment in immunoglobulin light chain amyloidosis based on free light chain measurement and cardiac biomarkers: impact on survival outcomes. J Clin Oncol. 2012 Dec 20;30(36):4541-9. doi: 10.1200/JCO.2011.37.7614. Epub 2012 Oct 22.