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AL AmyloidosisNCT04392960

Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis

A study testing [18F]Florbetaben in people with AL Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AL Amyloidosis
What is being tested?
[18F]Florbetaben
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
22 Jul 2020to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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.

Who cannot join

  • non-AL amyloidosis;
  • NYHA class IV;
  • PS-ECOG >3;
  • severe allergy to paramagnetic tracer;
  • severe claustrophobia;
  • pregnant or nursing women;

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

Other trials in Italy

About this study

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

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
AL Amyloidosis
Being tested
[18F]Florbetaben
Keywords
Amyloidosis, Prognosis, [18F]Florbetaben
Medical subject headings
Immunoglobulin Light-chain Amyloidosis, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FlorbetabenDrug

    Patients will undergo on the same day:

    • 18F-florbetaben PET-CT scans. The dose to be injected intravenously (6 second/mL) will be 370 MBq (for a 70 Kg patient);
    • standard assessment of clonal and organ disease;
    • echocardiography;
    • cardiac magnetic resonance.

    All the patients will undergo those evaluations at baseline and 6 months after treatment initiation.

Study groups in NCT04392960
Study groupRoleWhat they receive
18F-florbetaben PET-CT scansExperimentalNot described
Receives: Drug: [18F]Florbetaben

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the prognostic relevance of advanced imaging variables.

    • for CMR: T1, T2, ECV, indexed volumes, mass, ejection fraction (EF);

    Measured: 12 months after diagnosis

  2. Evaluation of the prognostic relevance of advanced imaging variables.

    • for echocardiography: left ventricular wall thickness (mLVW), EF, 2D-GLS, midwall fractional shortening (mFS), and stroke volume index (SVI);

    Measured: 12 months after diagnosis

  3. Evaluation of the prognostic relevance of advanced imaging variables.

    • for F-PET: myocardial uptake score.

    Measured: 12 months after diagnosis

  4. Evaluation of advanced imaging variables in response assessment.

    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.

    Measured: 6 months after initiation of chemotherapy targeting the amyloid plasma cell clone

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start22 Jul 2020
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04392960
Sponsor's protocol ID
AC-015-IT
Status last verified
Apr 2026
First submitted
27 Feb 2020
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Palladini 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.

    PubMed 20644111

  • Dispenzieri 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.

    PubMed 15365071

  • Wechalekar 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.

    PubMed 23479568

  • Palladini 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.

    PubMed 16434487

  • Palladini 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.

    PubMed 23091105

  • Mishra S, Guan J, Plovie E, Seldin DC, Connors LH, Merlini G, Falk RH, MacRae CA, Liao R. Human amyloidogenic light chain proteins result in cardiac dysfunction, cell death, and early mortality in zebrafish. Am J Physiol Heart Circ Physiol. 2013 Jul 1;305(1):H95-103. doi: 10.1152/ajpheart.00186.2013. Epub 2013 Apr 26.

    PubMed 23624626

  • Diomede L, Rognoni P, Lavatelli F, Romeo M, del Favero E, Cantu L, Ghibaudi E, di Fonzo A, Corbelli A, Fiordaliso F, Palladini G, Valentini V, Perfetti V, Salmona M, Merlini G. A Caenorhabditis elegans-based assay recognizes immunoglobulin light chains causing heart amyloidosis. Blood. 2014 Jun 5;123(23):3543-52. doi: 10.1182/blood-2013-10-525634. Epub 2014 Mar 24.

    PubMed 24665135

  • Weiss BM, Wong SW, Comenzo RL. Beyond the plasma cell: emerging therapies for immunoglobulin light chain amyloidosis. Blood. 2016 May 12;127(19):2275-80. doi: 10.1182/blood-2015-11-681650. Epub 2016 Feb 23.

    PubMed 26907632

  • Barros-Gomes S, Williams B, Nhola LF, Grogan M, Maalouf JF, Dispenzieri A, Pellikka PA, Villarraga HR. Prognosis of Light Chain Amyloidosis With Preserved LVEF: Added Value of 2D Speckle-Tracking Echocardiography to the Current Prognostic Staging System. JACC Cardiovasc Imaging. 2017 Apr;10(4):398-407. doi: 10.1016/j.jcmg.2016.04.008. Epub 2016 Sep 14.

    PubMed 27639764

  • Fontana M, Banypersad SM, Treibel TA, Abdel-Gadir A, Maestrini V, Lane T, Gilbertson JA, Hutt DF, Lachmann HJ, Whelan CJ, Wechalekar AD, Herrey AS, Gillmore JD, Hawkins PN, Moon JC. Differential Myocyte Responses in Patients with Cardiac Transthyretin Amyloidosis and Light-Chain Amyloidosis: A Cardiac MR Imaging Study. Radiology. 2015 Nov;277(2):388-97. doi: 10.1148/radiol.2015141744. Epub 2015 May 21.

    PubMed 25997029

Questions about this trial

What is this clinical trial studying?

A study testing [18F]Florbetaben in people with AL Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the prognostic relevance of advanced imaging variables. (time frame: 12 months after diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04392960, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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