A Phase 4 interventional study of F18 Florbetapir (amyvid) cardiac PET/CT imaging in Cardiac Amyloidosis, sponsored by Medical College of Wisconsin. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Medical College of Wisconsin · Phase 4, Interventional, and Diagnostic
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Among 58 studies in Amyloid Neuropathies, Familial with a site in United States — 23 open to participants now, 26 under way, 4 of them phase 3. Amyloid Neuropathies, Familial · United States.
Among the 58 studies in Amyloid Neuropathies, Familial with a site in United States, this one is the 36th largest by enrollment of the 38 interventional ones that give a count, is one of 4 that started in 2020, is one of 6 in phase 4, and was the 16th registered.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
Browse Amyloid Neuropathies, Familial studies →23 of the 58 studies in Amyloid Neuropathies, Familial with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Eidos Therapeutics, a BridgeBio company · Sites in United States
Ages 18–80
Mayo Clinic · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 30–80
University of Minnesota · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 69 Amyloid Neuropathies, Familial studies recruiting now, 53 (77%) set no upper age limit and 1 (1%) stops at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 17 · Phase 4 6
First in 2006; this study’s year is marked. 4 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4 is below the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Median enrollment 53 across the 38 interventional studies, 125 across the 20 observational. Of the 29 that completed or were terminated, 17 (59%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 58 have an industry lead sponsor. The 10 most frequent:
Medical College of Wisconsin is the lead sponsor of 549 studies on the registry; 123 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.
Medical College of Wisconsin has 1 study filed under Amyloid Neuropathies, Familial — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyloid Neuropathies, Familial with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05619302Phase 3Brigham and Women's HospitalMolecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis | 2026-12-31 |
| NCT07560306Phase 3Brigham and Women's Hospital[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy | 2027-03-30 |
| NCT07196839University of Texas Southwestern Medical CenterDetermining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study | 2026-12 |
| NCT07583823University of MinnesotaElevated Rate Pacing of Cardiac Amyloidosis | 2026-12-04 |
| NCT07062848Yale UniversityAn Observational Study Using Artificial Intelligence (AI) Algorithms on Electrocardiography (ECG), Point-of-care Ultrasound (POCUS), and Transthoracic Echocardiophy (TTE) to Estimate the Under-diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Across a Diverse Range of US Health Systems. | 2027-01 |
Add all 11 to your calendar (.ics) → With an account.
Among the 58 studies in Amyloid Neuropathies, Familial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a pilot study designed to assess for relative change in cardiac 18F Florbetapir uptake in patients with AL cardiac amyloidosis after appropriate chemotherapy.
Current research involving [18F]-florbetapir in relationship to cardiac amyloid has taken advantage of the ability of the radiopharmaceutical to bind specifically to amyloid fibrils. It has previously been established that the degree of radiotracer uptake correlates with the density of Beta-amyloid plaque. The ability to quantify this uptake makes [18F]-florbetapir imaging a potential tool to evaluate cardiac response in patients undergoing therapy for AL amyloidosis. It would provide a much-needed tool to monitor cardiac response to chemotherapy to potentially adjust chemotherapy if response was not adequate. It could also provide a tool by which investigators would be able to evaluate new therapies designed to decrease the burden of formed amyloid fibrils within the heart.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Patients enrolled will be patients \> 18 years of age with a clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis) with plans to undergo plasma cell directed chemotherapy.
Drug: F18 Florbetapir (amyvid) cardiac PET/CT imaging
Patients with cardiac amyloidosis (AL) undergoing planned plasma cell directed chemotherapy will have F-18 florbetapir (amyvid) cardiac PET/CT imaging prior to starting chemotherapy and six months after onset of treatment.
Also known as: Amyvid
Relative Change in Cardiac Uptake of 18F Florbetapir Prior to Chemotherapy and After Six Months of Chemotherapy.
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
Time frame: six months
Six Minute Walk Test
Change in Distance covered on six minute walk test at onset of chemotherapy will be compared to distance covered after six months of chemotherapy Distance at onset vs six months will be correlated with changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months. Overall change in distance walked during 6 minute walk prior to starting chemotherapy and after 12 months of chemotherapy will be compared to any changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months.
Time frame: twelve months
Hematologic Response
correlation of hematologic response to treatment at 6 months and 18F florbetapir cardiac uptake changes between 0 and 6 months. Hematologic response after 12 months will also be compared to any changes in 18F florbetapir cardiac uptake between 0 and 6 months.
Time frame: 12 months
Cardiac Response
Cardiac response as defined by changes in NT proBNP (N Terminal proBNP) levels and cardiac Troponin T levels will be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months. Changes in Cardiac troponin T and NT pro BNP levels after 12 months will also be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months.
Time frame: 12 months
Patient Related Outcomes
Correlation of hematologic response to results of patient related outcomes survey completed at 0, 6, and 12 months. Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely.
Time frame: 12 months
Patient Related Outcomes
Correlation of cardiac response to results of patient related outcomes survey completed at 0, 6, and 12 months Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely.
Time frame: 12 months
Patient Related Outcomes
Correlation changes in 18F florbetapir cardiac uptake between 0 and 6 months to results of patient related outcomes survey completed at 0, 6, and 12 months Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely.
Time frame: 12 months
| Milestone | Patients With AL Cardiac Amyloid |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Death | 3 |
Levels of 18F florbetapir cardiac uptake at onset of chemotherapy will be compared with levels after six months of chemotherapy on repeat imaging.
No measurements were reported for this outcome.
Change in Distance covered on six minute walk test at onset of chemotherapy will be compared to distance covered after six months of chemotherapy Distance at onset vs six months will be correlated with changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months. Overall change in distance walked during 6 minute walk prior to starting chemotherapy and after 12 months of chemotherapy will be compared to any changes in 18F florbetapir cardiac uptake on cardiac PET/CT imaging between 0 and 6 months.
No measurements were reported for this outcome.
correlation of hematologic response to treatment at 6 months and 18F florbetapir cardiac uptake changes between 0 and 6 months. Hematologic response after 12 months will also be compared to any changes in 18F florbetapir cardiac uptake between 0 and 6 months.
No measurements were reported for this outcome.
Cardiac response as defined by changes in NT proBNP (N Terminal proBNP) levels and cardiac Troponin T levels will be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months. Changes in Cardiac troponin T and NT pro BNP levels after 12 months will also be correlated with changes in 18F florbetapir cardiac uptake between 0 and 6 months.
No measurements were reported for this outcome.
Correlation of hematologic response to results of patient related outcomes survey completed at 0, 6, and 12 months. Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely.
No measurements were reported for this outcome.
Correlation of cardiac response to results of patient related outcomes survey completed at 0, 6, and 12 months Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely.
No measurements were reported for this outcome.
Correlation changes in 18F florbetapir cardiac uptake between 0 and 6 months to results of patient related outcomes survey completed at 0, 6, and 12 months Patient reported outcomes survey was developed using PROMIS short form v2.0-Physical Function 8b, PROMIS short form v1.0 Dyspnea Severity 10a, and PROMIS short form v1.0 Fatigue 8a. Measures used in the patient survey were obtained from the health measures website at www.healthmeasures.net/promis, which can be accessed for further information. Scale 1-5 with one being not at all and 5 being very likely.
No measurements were reported for this outcome.
Collected over From enrollment up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With AL Cardiac Amyloid | 3/4 (75%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Patients With AL Cardiac Amyloid |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Patients With AL Cardiac Amyloid |
|---|---|
| Female | 1 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Patients With AL Cardiac Amyloid |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ethnicity (NIH/OMB)(Participants) | Patients With AL Cardiac Amyloid |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Six-Minute Walk(yards) | Patients With AL Cardiac Amyloid |
|---|---|
| Mean | 34.7 ± 5.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2020 to primary completion in May 2023, 31 months.
Results were first posted in Jul 2026, 3 years 2 months after primary completion.
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Amyloid Neuropathies, Familial →
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