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Enrolling By Invitation
NCT07103863
Multimodal Radiomics Model (18F-FAPI PET/CT + CMR) for AL Cardiac Amyloidosis Prognosis
Conditions: AL Amyloidosis (AL), Cardiac Amyloidosis
Sex: All
Healthy volunteers: No
Enrollment: 49
Sponsor: Beijing Anzhen Hospital
Location: Beijing Anzhen Hospital Beijing Beijing Municipality
Summary
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 \
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07103863). StuddyBuddy aggregates publicly available trial information.