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PET/CT Imaging with Florbetaben/FNOS for Cardiac Amyloidosis

Phase < 1

Waitlist Available

Led By Paco Bravo

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have cardiac involvement as defined by specific clinical signs and symptoms, diagnostic tests, and biomarker levels

Participants will be at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing how two different types of PET scans can image a heart disorder called amyloidosis. There will be two groups, one receiving a scan with the drug 18F-NOS, the other with Florbetaben. Subjects will be assigned to a group when they agree to be in the study.

Who is the study for?

This trial is for adults over 18 with AL amyloidosis, a heart disorder, who are about to start or have had limited treatment. They must show specific clinical signs and be at least six months past their last therapy if relapsed. Pregnant or breastfeeding women and those with conditions that could risk safety or participation success are excluded.

What is being tested?

The study tests two PET/CT scan methods using different imaging drugs (18F-NOS and Florbetaben) to visualize cardiac amyloidosis in patients. Participants will be randomly assigned to one of the groups upon agreeing to join the study.

What are the potential side effects?

While not explicitly listed, potential side effects may include reactions related to the imaging drugs used for PET/CT scans such as discomfort at injection site, allergic reactions, or exposure-related risks from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart is affected by my condition, confirmed by tests and symptoms.

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I am 18 years old or older.

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I have been diagnosed with AL amyloidosis and am about to start treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure uptake of [18F]NOS and Florbetaben in patients with AL before and ~4 months (2 +/- weeks) after starting standard therapy using PET/CT

Secondary study objectives

Describe fold changes in Florbetaben uptake in patients who have an NT-proBNP response at ~4 months vs patients who have no response or progression

Describe fold changes in [18F]NOS uptake in patients who have a complete response or very good partial response vs patients who have a partial or no response to therapy at ~4 months.

Describe fold changes in [18F]NOS uptake in patients who have an NT-proBNP response at ~4 months vs patients who have no response or progression