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

ConditionLight Chain Cardiac Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: 11C-PIB PET/CT dynamic imagingExperimental treatment 1 intervention
Group B: 18F-Florbetapir PET/CT dynamic imagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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