Imaging Model to Predict Outcomes in Light Chain Cardiac Amyloidosis
Tests a scan-based model to predict outcomes in people with heart amyloidosis.
Plain-language title generated from the registry record
Registry title: Multimodal Radiomics Model (18F-FAPI PET/CT + CMR) for AL Cardiac Amyloidosis Prognosis
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with light-chain (AL) cardiac amyloidosis, confirmed by biopsy, who are getting standard treatment. It tests whether two heart scans together can predict survival at 12 months.
- Sex
- Men and women can join.
- Disease stage
- AL cardiac amyloidosis confirmed by biopsy. If the biopsy was taken outside the heart, NT-proBNP must be above 332 pg/mL and the average left heart wall thickness above 12 mm, with high blood pressure and other causes ruled out.
- Earlier treatment
- People must be getting standard AL cardiac amyloidosis treatment, including chemotherapy and supportive care.
- Biomarker or test result
- Blood NT-proBNP above 332 pg/mL is needed for those confirmed by a biopsy outside the heart.
Main reasons for not taking part
- Active infection
- Advanced cancer with expected survival under 12 months
- Severe memory or thinking problems
- Limited mobility or other conditions that make scans or follow-up hard to complete
Read by machine on 9 November 2026.
Where in China
- Beijing Anzhen HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Anzhen Hospital
- Trial code
- NCT07103863
- Record updated
- 10 September 2026
- Original description
1. Goal of the Study:Read full original descriptionShow less
A Prospective Study on the Prognostic Assessment of Light Chain Type Cardiac Amyloidosis (AL-CA) Based on Multimodal Fusion Radiomics Model of 18F-FAPI PET/CT and 3D CMR
1. Goal of the Study:
The goal of this prospective observational study is to develop and validate a novel, non-invasive method for predicting the prognosis of patients with light-chain cardiac amyloidosis (AL-CA). This method integrates advanced multi-modal imaging techniques and artificial intelligence (radiomics) to provide early and accurate assessment of treatment response and survival outcomes. 2. Main Question:
Can a multi-modal radiomics model, based on the fusion of [¹⁸F]FAPI PET/CT (assessing fibroblast activation) and 3D Cardiac MRI (CMR) (assessing structural damage) imaging data, accurately predict 12-month all-cause mortality and dynamically track disease progression in patients with AL-CA receiving standard care? 3. Participants:
Population: Patients diagnosed with AL-CA (confirmed by endomyocardial biopsy or extracardiac biopsy plus specific cardiac criteria: NT-proBNP >332 pg/mL, mean left ventricular wall thickness >12 mm, excluding hypertension/other causes).
Setting: Single-center study at Beijing Anzhen Hospital, Capital Medical University.
Number: 49 patients (calculated sample size accounting for dropouts).
Key Criteria:
Inclusion: Confirmed AL-CA diagnosis, receiving standard AL-CA treatment (chemotherapy e.g., Daratumumab-based regimen + supportive cardiac care).
Exclusion: Active infection, advanced malignancy (life expectancy <12 months), severe cognitive impairment/immobility affecting imaging compliance/follow-up. 4. Study Design \& Procedures:
Design: Single-center prospective cohort study.
Intervention: Participants receive standard-of-care treatment for AL-CA as per guidelines (chemotherapy regimen based on Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone; tailored cardiac support including diuretics, rate control, anticoagulation if needed).
Procedures:
Baseline: Upon enrollment, participants undergo comprehensive assessment: [¹⁸F]FAPI PET/CT scan, 3D CMR scan, blood tests (NT-proBNP, troponin, free light chains, etc.), clinical staging (Mayo 2012), functional assessment (NYHA class), quality of life questionnaire (KCCQ).
Imaging: Specialized software (Siemens True D) performs cross-platform fusion of PET/CT and 3D CMR images. Radiomics features are extracted from the fused images using dedicated software (Siemens FeAture Explorer).
Follow-up:
Clinical: Every 3 months (symptoms, medication adherence, adverse events, lab tests including NT-proBNP).
Imaging: Repeat [¹⁸F]FAPI PET/CT and 3D CMR scans at 6 months post-baseline. Radiomics features are extracted again.
Endpoints: Primary endpoint is 12-month all-cause mortality. Secondary endpoints include re-hospitalization rates and changes in NYHA class. Follow-up continues until the 12-month endpoint for all participants.
Data Analysis: Machine learning (LASSO-Cox regression) is used to select key radiomics features from baseline and 6-month scans and integrate them with quantitative imaging parameters (FAPI uptake volume, SUVmax, LGE burden, ECV) and clinical data to build prognostic models predicting 12-month survival. 5. Comparison:
Researchers will compare the predictive performance of the developed multi-modal radiomics model against:
* Traditional clinical biomarkers: NT-proBNP levels and Mayo Clinic staging. * Standard quantitative imaging parameters alone: Such as myocardial FAPI uptake volume, SUVmax, or CMR-derived extracellular volume (ECV) measured at baseline and 6 months.
The goal is to demonstrate superior accuracy in predicting 12-month all-cause mortality using the integrated radiomics approach.
Inclusion: Pathologically confirmed AL cardiac amyloidosis (AL-CA) by endocardial biopsy; Pathologically confirmed AL-CA by extracardiac (bone marrow, adipose tissue, tongue muscle, etc.) biopsy, with serum N-terminal pro-brain natriuretic peptide (NT-proBNP) > 332 pg/mL, left ventricular mean wall thickness > 12 mm, and exclusion of hypertension and other secondary causes of left ventricular hypertrophy; Receiving standard AL-CA treatment regimens (including chemotherapy and supportive therapy).
Exclusion: Complicated with active infection or advanced malignant tumor (expected survival time < 12 months); Presence of severe cognitive impairment, limited mobility, or other conditions that affect compliance with imaging examinations or the completeness of follow-up.