Advanced Imaging Techniques for Cardiomyopathy

(MICA Trial)

Overseen By Sharmila Dorbala, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Antibiotics, Antivirals, Antifungals, Antiparasitics

Disqualifiers: Heart disease, Renal dysfunction, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

171 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new imaging methods to better understand heart issues in people with light chain amyloidosis, a condition where proteins accumulate in organs and can cause heart problems. The researchers aim to find ways to visualize these protein deposits in the heart more clearly, potentially aiding in the development of new treatments. The trial includes several groups, such as those with heart failure and multiple myeloma, to compare results. People with light chain amyloidosis or heart failure might be suitable if they can undergo scans and tests, including F-18 florbetapir/C-11 acetate PET, MRI (Magnetic Resonance Imaging), and N-13 ammonia PET. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to improved diagnostic tools and treatments for heart conditions.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these advanced imaging techniques are safe for cardiac amyloidosis patients?

Research shows that the imaging methods used in this trial are generally easy for patients to handle. Studies on F-18 florbetapir PET scans indicate they can safely detect heart issues related to amyloidosis without requiring a heart biopsy. This makes them non-invasive and less risky for patients.

Similarly, MRI scans often examine the heart and are safe for most people. They do not use radiation, making them suitable for repeated imaging.

N-13 ammonia PET scans have also proven safe and effective. Studies reviewed report no negative reactions, making it a reliable way to assess blood flow in the heart.

Overall, these imaging techniques have a strong safety record, making them a promising option for studying heart conditions in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the advanced imaging techniques being explored for cardiomyopathy because they offer a fresh perspective on diagnosing and understanding the condition. Unlike traditional methods that often rely heavily on echocardiograms or standard MRIs, these new techniques use F-18 florbetapir and C-11 acetate PET scans, which can provide more detailed insights into heart muscle activity and amyloid deposits. Additionally, the use of N-13 ammonia PET scans during physical stress tests could reveal how well blood flows through the heart under exertion. These methods aim to provide a clearer picture of heart health, potentially leading to earlier and more accurate diagnoses.

What evidence suggests that these advanced imaging techniques are effective for cardiomyopathy?

In this trial, participants will undergo various advanced imaging techniques to assess cardiomyopathy. F-18 florbetapir PET scans, administered to some participants, have shown promise in previous studies for early detection of heart amyloid deposits, potentially identifying the disease before symptoms appear. MRI, another imaging technique used in this trial, has proven useful in distinguishing between cardiac amyloidosis and other heart problems, aiding in monitoring disease progression and predicting outcomes. Additionally, N-13 ammonia PET scans, conducted on a subset of participants, have effectively identified blood flow issues in the heart related to cardiac amyloidosis. These imaging tools could provide a clearer picture of heart health, potentially leading to better treatment plans. ^{2 3 6 7 8}

Who Is on the Research Team?

Sharmila Dorbala, MBBS, MPH

Principal Investigator

Brigham and Women's Hospital (AHA and NIH Studies)

Ronglih Liao, PhD

Principal Investigator

Stanford School of Medicine (AHA Study)

Rodney Falk, MD

Principal Investigator

Brigham and Women's Hospital (NIH Study)

Are You a Good Fit for This Trial?

Adults diagnosed with light chain amyloidosis or heart failure without amyloidosis, able to exercise and consent. Excludes those with severe coronary artery disease, claustrophobia that sedatives can't help, pregnancy, significant kidney dysfunction, certain metallic implants (except MR compatible devices for control subjects), on dialysis, unable to attend follow-up visits or lie flat for an hour.

Inclusion Criteria

For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study.

Willing and able to provide consent

I have been diagnosed with heart failure, not caused by amyloidosis.

Exclusion Criteria

I have a significant blockage in a heart artery.

I cannot lie flat for an hour due to heart failure.

Inability to return to BWH 12 month clinical evaluation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline imaging and blood analysis, including F-18 florbetapir PET, C-11 acetate PET, MRI, and heavy metal analysis

1-2 weeks

1 visit (in-person)

Treatment and Monitoring

Participants receive chemotherapy and are monitored for changes in myocardial structure, function, and metabolism using advanced imaging techniques

12 months

3 visits (in-person) at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• F-18 florbetapir/C-11 acetate PET
• MRI
• N-13 ammonia PET

Trial Overview The trial is testing advanced imaging methods like F-18 florbetapir/C-11 acetate PET scans and MRI to visualize cardiac amyloid deposits in patients with cardiac amyloidosis. The goal is to understand the mechanisms of cardiac dysfunction better.

How Is the Trial Designed?

Group I: Heart Failure Experimental Treatment 2 Interventions

10 individuals with diagnosis of heart failure without amyloidosis by standard criteria will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline..

Group II: Active AL cardiac amyloidosis Experimental Treatment 3 Interventions

75 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of blood of the heart, as well as the heavy metal analysis of the blood at baseline, 6 months and 12 months after initiation of chemotherapy. 25 of these individuals will also undergo a N-13 ammonia PET scan of the heart following supine bicycle stress at baseline and at 6 months after initiation of chemotherapy.

Group III: Active AL Pre-CMP Experimental Treatment 2 Interventions

36 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and without cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline. At 6 months they will undergo a research MRI of the heart and at 12 months they will have a clinical follow up. Subjects with contraindications to Cardiac MRI or gadolinium contrast may still be eligible for study participation.

Group IV: Multiple Myeloma Controls Active Control 1 Intervention

25 individuals with diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria will undergo urine and blood testing only.

Group V: Remission AL cardiac amyloidosis Active Control 2 Interventions

25 individuals with light chain systemic amyloidosis with cardiac involvement and plasma cell dyscrasia in hematological remission (complete hematological remission or very good partial response-differential free light chain (dFLC)\<40 mg/dL for \> 1 year prior to enrollment) will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI scan of the heart as well as a heavy metal analysis of the blood at baseline.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34250046/

Pilot Study of F18-Florbetapir in the Early Evaluation ... We sought to assess the performance of F18-florbetapir PET in patients with a potential for cardiac amyloidosis in order to identify early disease.

2. jnm.snmjournals.org jnm.snmjournals.org/content/59/supplement_1/228

Myocardial Energetics in AL and ATTR Cardiac Amyloidosis 2024. 18F Florbetapir PET/CT cardiac amyloid imaging in patients with systemic amyloidosis. Karen Wells, J Nucl Med, 2013. Impact of ROI ...

3. withpower.com withpower.com/trial/phase-cardiomyopathies-3-2016-99550?condition=&query=Advanced+PET%2FMRI+Imaging&overallStatus=Recruiting&hasNoPlacebo=false

Advanced Imaging Techniques for Cardiomyopathy Trial Overview The trial is testing advanced imaging methods like F-18 florbetapir/C-11 acetate PET scans and MRI to visualize cardiac amyloid deposits in ...

4. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.693194/full

Pilot Study of F18-Florbetapir in the Early Evaluation ... This pilot study sought to test F18-florbetapir for early detection of cardiac amyloid deposits in asymptomatic patients.

5. revespcardiol.org revespcardiol.org/en-cardiac-amyloidosis-detected-using-f-flo-articulo-S1885585716300172

Cardiac Amyloidosis Detected Using 18F-florbetapir PET/CT Imaging with 18F-florbetapir PET/CT permits the early and noninvasive detection of cardiac amyloid, precluding the need for myocardial biopsy. In addition ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8267881/

Pilot Study of F18-Florbetapir in the Early Evaluation ... We sought to assess the performance of F18-florbetapir PET in patients with a potential for cardiac amyloidosis in order to identify early disease.

7. aetna.com aetna.com/cpb/medical/data/1_99/0071.html

Positron Emission Tomography (PET) - Medical Clinical ... Clark et al (2011) examined if florbetapir F 18 PET imaging performed during life accurately predicts the presence of β-amyloid in the brain at autopsy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0914508725000176

Molecular imaging of cardiovascular disease Myocardial 18F-florbetapir uptake was associated with major adverse cardiac events in 81 patients with AL amyloidosis [217]. 124I-Evuzamitide is a tracer based ...