Multimodal Radiomics Model (18F-FAPI PET/CT + CMR) for AL Cardiac Amyloidosis Prognosis

NCT07103863 | Enrolling By Invitation DMC

• 2 other identifiers: BeijingAnzhen dongweiHigh Level research funding
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

AL Amyloidosis (AL); Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

• 12-month survival

  12 months

Study Arms (1)

Rationale: AL-CA: Clearly identifies the disease population (Light-chain Cardiac Amyloidosis). Mul

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Design 1. Study Type: Single-center prospective cohort study (evaluating the prognostic value of radiomics parameters under standardized treatment). 2. Study Population: Patients with suspected or confirmed cardiac light-chain amyloidosis (AL-CA) via endocardial or extracardiac biopsy who are admitted to the Department of Hematology, Beijing Anzhen Hospital, from Feburary 2025 to August 2028.

You may qualify if:

• Pathologically confirmed AL cardiac amyloidosis (AL-CA) by endocardial biopsy;
• Receiving standard AL-CA treatment regimens (including chemotherapy and supportive therapy).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors

Study Officials

• wei dong, MD,PHD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)