ClinicalTrials.gov record NCT07829705

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

A Follow-Up Study to Monitor Therapeutic Response in Light Chain Cardiac Amyloidosis Using Beta-amyloid PET/CT

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Study for people with light chain cardiac amyloidosis. Participants undergo a baseline beta‑amyloid PET/CT scan (11C-PIB or 18F-Florbetapir) and a repeat dynamic PET/CT about 12 months later after plasma cell–directed therapy. Demographic, clinical and PET imaging data are collected to characterize changes since the baseline scan.

What it is studying. The study tests whether myocardial uptake of beta‑amyloid–binding PET tracers (11C‑PIB or 18F‑Florbetapir) changes from a baseline scan to a scan performed about 12 months after starting plasma cell–directed therapy in people with AL cardiac amyloidosis.

What the researchers hope to learn. To determine whether changes in PET tracer measures — myocardial retention index, SUVmean, and SUV ratio (SUVR) — can be detected from baseline to 12 months using 11C‑PIB or 18F‑Florbetapir in people treated for AL cardiac amyloidosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • 11C-PIB
  • 18F-Florbetapir

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will have a baseline heart PET/CT scan and a follow-up heart PET/CT scan about 12 months after starting plasma cell or targeted therapy to assess tracer uptake. Depending on the study arm, the scan will use either 11C-PIB (dynamic imaging about 30 minutes) or 18F-Florbetapir (dynamic imaging about 60 minutes); each scan involves injection of the tracer by a PET-certified medical professional. Blood samples for heavy metal analysis will be collected at baseline and every 12 months after initiation of therapy.

How the study is structured. Interventional, non-randomized study with two parallel imaging arms using either 11C‑PIB or 18F‑Florbetapir. Participants receive a dynamic PET/CT scan at baseline and a follow-up dynamic PET/CT at about 12 months after initiating therapy. The 11C‑PIB scan is described as a 30‑minute dynamic scan and the 18F‑Florbetapir scan as a 60‑minute dynamic scan. Blood samples for heavy metal analysis are collected at baseline and every 12 months as described in the registry. There is no masking.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Light Chain Cardiac Amyloidosis. Does it apply to my diagnosis?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 3, 2020
Primary completion
Jul 1, 2025
Study completion
Dec 31, 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Sep 21, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking Union Medical College Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Peking Union Medical College HospitalRecruiting

    Beijing, 100730 · China

Terms used on this page · explanations by MedicalUpdates.ai

prospective cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
PET/CT
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
Echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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