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Heart scan tracer may reveal Chemo's effect on amyloid buildup

NCT ID NCT03333551

Disease control Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This pilot study tests whether a special PET scan tracer called 18F florbetapir can detect changes in amyloid protein deposits in the heart of people with AL cardiac amyloidosis who are receiving chemotherapy. Four participants will have a PET/CT scan before starting chemotherapy and again after six months of treatment. The goal is to see if the tracer's uptake in the heart changes as chemotherapy reduces amyloid levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F florbetapir (Amyvid) cardiac PET/CT imaging
What this could lead to
If successful, this imaging method could help doctors monitor how well chemotherapy is reducing amyloid buildup in the heart.
What could go wrong
This is a very small pilot study with only 4 participants, so results may not apply broadly. The imaging agent is not yet proven to track treatment response reliably.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

4 people

The number who actually took part.

Started

Oct 2020

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged \> 18 years are eligible. 2. Patient must provide informed consent to participate in the study protocol. 3. All patients must have clinical diagnosis of cardiac AL amyloidosis (typical echocardiographic or cardiac MRI findings, NT-ProBNP levels above 332 pg/mL, cardiac or extra cardiac histological evidence of light chain amyloidosis). 4. Planned plasma cell-directed chemotherapy. 5. A negative pregnancy test will be required for all women of child bearing potential, breast feeding is not permitted. 6. Patients must be able to undergo PET-CT imaging 7. Patients must be able to complete 6-minute walk test Exclusion Criteria: 1. Severe claustrophobia 2. Pregnancy 3. Allergy to F-18 florbetapir

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Amyloid Neuropathies, Familial amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac amyloidosis

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

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