Beta-amyloid PET/CT to Measure Potential Therapeutic Response in AL-CA

NCT07829705 | Recruiting Phase 2

• 1 other identifier: Abeta-MTRALCA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single center, prospective cohort study that is evaluating the ability of beta-amyloid dynamic PET/CT to detect potential therapeutic changes in subjects under treatment for AL-CA after one year had elapsed since their baseline beta-amyloid PET/CT. Demographic, clinical and PET imaging data were collected to characterize potential changes since their baseline scans.

Conditions

Light Chain Cardiac Amyloidosis

Keywords

Light Chain Cardiac Amyloidosis, Beta-amyloid PET/CT, Therapeutic Response

Outcome Measures

Primary Outcomes (3)

• Change in 11C-PIB/18F-Florbetapir myocardial retention index from baseline to 12 months

  For calculation of the 11C-PIB retention index (RI), the mean tissue concentration between 10 and 20 min was divided by the integral of the blood time activity curve from 0 to 15 min after injection. For calculation of the 18F-Florbetapir RI, the mean tissue concentration between 10 and 30 min was divided by the integral of the blood time activity curve from 0 to 20 min after injection.

  Baseline and 12months

• Change in 11C-PIB/18F-Florbetapir myocardial mean standardized uptake value (SUVmean) from baseline to 12 months

  Median percentage change in left ventricular SUVmean. The standardized uptake value (SUV) of the myocardium was measured by drawing the contour of the whole left ventricle at an approximate thickness of 10 mm from the base to the apex.

  Baseline and 12months

• Change in 11C-PIB/18F-Florbetapir myocardial SUV ratio (SUVR) from baseline to 12 months

  For calculation of the 11C-PIB SUVR, it was defined as the SUVmean of the myocardial VOI divided by the SUVmean of the left atrium VOI between 10 and 20 minutes. For calculation of the 18F-Florbetapir SUVR, it was defined as the SUVmean of the myocardial VOI divided by the SUVmean of the left atrium VOI between 10 and 30 minutes.

  Baseline and 12months

Study Arms (2)

11C-PIB PET/CT dynamic imaging

EXPERIMENTAL

Individuals with light chain systemic amyloidosis with cardiac involvement will undergo baseline 11C-PIB PET/CT dynamic scan (30min) and a follow-up PET/CT dynamic scan at baseline and at 12 months after initiation of plasma cell therapy/targeted therapy, as well as the heavy metal analysis of the blood at baseline, and every 12 month after initiation of therapy.

Drug: 11C-PIB

18F-Florbetapir PET/CT dynamic imaging

EXPERIMENTAL

Individuals with light chain systemic amyloidosis with cardiac involvement will undergo baseline 18F-Florbetapir PET/CT dynamic scan (60min) and a follow-up PET/CT dynamic scan at baseline and at 12 months after initiation of plasma cell therapy/targeted therapy, as well as the heavy metal analysis of the blood at baseline, and every 12 month after initiation of therapy.

Drug: 18F-Florbetapir

Interventions

11C-PIB DRUG

A dosage range between 5.0-20.0 mCi of 11C-PIB will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.

11C-PIB PET/CT dynamic imaging

18F-Florbetapir DRUG

A dosage range between 6.0-12.0 mCi of 18F-Florbetapir will be injected by a PET-certified medical professional followed by 5ml 0.9% sodium chloride (normal saline) flush.

18F-Florbetapir PET/CT dynamic imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 y；
• were proven newly diagnosed AL-CA by standard criteria;
• subsequently received first-line therapies including anti-plasma cell therapy or targeted therapy;
• must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.

You may not qualify if:

• received therapy with an approved treatment (e.g., Bortezomib, Daratumumab) prior to enrollment;
• pregnancy or breastfeeding;
• severe claustrophobia;
• any condition deemed by the investigator to interfere with study results or increase participant risk.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole; florbetapir

Central Study Contacts

Li Huo

CONTACT

+86 18612672038; huoli@pumch.cn

Xuezhu Wang

CONTACT

+86 19801117760; xuezhu1226@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: September 21, 2026
• Study Start: June 3, 2020
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 2 years after the publication of the main results

Locations

CN (1)