A Phase 2 interventional study of 11C-PIB and 18F-Florbetapir in Light Chain Cardiac Amyloidosis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Diagnostic
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.
Light chain (AL) amyloidosis is a clonal plasma cell disorder that involves the deposition of misfolded monoclonal immunoglobulin light chains in the interstitial area, resulting in amyloid fibril aggregation. Despite advances in diagnostic work-up and treatment, AL amyloidosis frequently manifests as infiltrative cardiomyopathy, a particularly lethal form of heart failure. The diagnosis of cardiac amyloidosis (CA) is often overlooked and delayed due to nonspecific clinical symptoms and comorbidities. AL-CA is highly fatal without therapy; even with state-of-the-art therapies, including daratumumab, mortality remains high in the first year. Moreover, despite successful therapy, progressive heart failure, remains a significant clinical challenge in some patients and is attributed to residual amyloid fibril infiltration degree. Early and accurate assessment of changes in amyloid burden in response to therapy remains a challenge.
Currently, evaluation of response to plasma cell therapy relies on circulating AL biomarkers, which are not specific for reduction in amyloid burden. Echocardiography and CMR are used to evaluate myocardial functional and structural changes in AL amyloidosis after plasma cell-directed therapy. However, these measures lack specificity for amyloid fibrils. By contrast, beta-amyloid-binding tracers, such as 11C-PIB, 18F-Florbetapir, are emerging as quantitative and specific molecular markers of cardiac amyloid. These tracers have demonstrated high sensitivity and specificity for cardiac amyloid in preclinical and clinical studies. The investigators hypothesis that, changes in amyloid-binding tracer uptake may signal early molecular changes in myocardial amyloid.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 189 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12months
Plan to share: Yes — Available upon request
Supporting information: Study protocol
Time frame: Within 2 years after the publication of the main results
No publications or documents are linked to this record.
Ran from Jun 2020 to primary completion in Jul 2025, 60 months.
Of 24 phase 2 interventional studies under Amyloidosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 64. This study's 60 months is above that.
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Studies of the drug tested here: Pittsburgh compound B
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