Light Chain Cardiac AmyloidosisPhase 2Abeta-MTRALCANCT07829705
Beta-amyloid PET/CT to Measure Potential Therapeutic Response in AL-CA
A Phase 2 study testing 11C-PIB and 18F-Florbetapir in people with Light Chain Cardiac Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Light Chain Cardiac Amyloidosis
- What is being tested?
- 11C-PIB and 18F-Florbetapir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2020to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Peking Union Medical College Hospital, +86 69156874, pumchkyc@126.com
About this study
Official title: A Follow-Up Study to Monitor Therapeutic Response in Light Chain Cardiac Amyloidosis Using Beta-amyloid PET/CT
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.
Read the detailed description
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.
- Conditions
- Light Chain Cardiac Amyloidosis
- Being tested
- 11C-PIB, 18F-Florbetapir
- Keywords
- Light Chain Cardiac Amyloidosis, Beta-amyloid PET/CT, Therapeutic Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-PIBDrug
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.
18F-FlorbetapirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 18F-Florbetapir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start3 Jun 2020
- Primary completion1 Jul 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Chain Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829705
- Sponsor's protocol ID
- Abeta-MTRALCA
- Acronym
- Abeta-MTRALCA
- Status last verified
- May 2026
- First submitted
- 17 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-Up Study to Monitor Therapeutic Response in Light Chain Cardiac Amyloidosis Using Beta-amyloid PET/CT
- ClinicalTrials.gov ID
- NCT07829705
- Acronym / sponsor ID
- Abeta-MTRALCA / Abeta-MTRALCA
- Conditions
- Light Chain Cardiac Amyloidosis
- Keywords
- Light Chain Cardiac Amyloidosis, Beta-amyloid PET/CT, Therapeutic Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 11C-PIB PET/CT dynamic imaging | Experimental | Drug: 11C-PIBIndividuals 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. |
| 18F-Florbetapir PET/CT dynamic imaging | Experimental | Drug: 18F-FlorbetapirIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-PIBA 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. | Drug | 11C-PIB PET/CT dynamic imaging |
| 18F-FlorbetapirA 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. | Drug | 18F-Florbetapir PET/CT dynamic imaging |
Primary outcome
Change in 11C-PIB/18F-Florbetapir myocardial retention index from baseline to 12 months
Time frame: Baseline and 12months
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.
Change in 11C-PIB/18F-Florbetapir myocardial mean standardized uptake value (SUVmean) from baseline to 12 months
Time frame: Baseline and 12months
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.
Change in 11C-PIB/18F-Florbetapir myocardial SUV ratio (SUVR) from baseline to 12 months
Time frame: Baseline and 12months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 11C-PIB and 18F-Florbetapir in people with Light Chain Cardiac Amyloidosis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Huo (+86 18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 11C-PIB/18F-Florbetapir myocardial retention index from baseline to 12 months (time frame: Baseline and 12months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.