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PET/CT Imaging with Florbetaben/FNOS for Cardiac Amyloidosis

Q: Has the potential of Florbetaben been explored previously through scientific inquiry?

At the moment, there are 7 Florbetaben studies that remain active with none of them in their third phase. Interestingly enough, 9 different locations around the country are running trials for this compound and a majority of those sites can be found in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City.

Q: How many participants have been recruited for this experiment?

Affirmative. As sourced from clinicaltrials.gov, this medical research is actively recruiting candidates with the trial's initial post date being October 1st 2019 and its most recent update on September 29th 2022. The study requires 20 participants to be recruited across a single site.

Q: Is the research protocol recruiting participants at this time?

Affirmative. According to clinicaltrials.gov, this medical experiment is still in need of applicants; the original posting date was October 1st 2019 and it was most recently revised on September 29th 2022. The study requires 20 volunteers from a single centre.

Q: Is this a pioneering research project?

Presently, there are 7 live trials for Florbetaben across 2 states and 3 towns. First trialled in 2010 by Bayer with 161 participants, this drug has been evaluated 12 times over the past decade through its N/A approval stage.

Phase < 1

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am 18 years old or older.

Select...

I have either not started treatment, completed one cycle, or it's been 6 months since my last treatment.

Select...

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Inflammation groupExperimental Treatment1 Intervention

Patient diagnosed with Cardiac Amyloidosis

Group II: Amyloid groupExperimental Treatment1 Intervention

Patient diagnosed with Cardiac Amyloidosis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Florbetaben (18F)

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,068 Total Patients Enrolled

Paco BravoPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Cardiac Amyloidosis Clinical Trial 2023: Florbetaben Highlights & Side Effects. Trial Name: NCT04105634 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the potential of Florbetaben been explored previously through scientific inquiry?

"At the moment, there are 7 Florbetaben studies that remain active with none of them in their third phase. Interestingly enough, 9 different locations around the country are running trials for this compound and a majority of those sites can be found in New york City."

Answered by AI

How many participants have been recruited for this experiment?

"Affirmative. As sourced from clinicaltrials.gov, this medical research is actively recruiting candidates with the trial's initial post date being October 1st 2019 and its most recent update on September 29th 2022. The study requires 20 participants to be recruited across a single site."

Answered by AI

Is the research protocol recruiting participants at this time?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still in need of applicants; the original posting date was October 1st 2019 and it was most recently revised on September 29th 2022. The study requires 20 volunteers from a single centre."

Answered by AI

Is this a pioneering research project?

"Presently, there are 7 live trials for Florbetaben across 2 states and 3 towns. First trialled in 2010 by Bayer with 161 participants, this drug has been evaluated 12 times over the past decade through its N/A approval stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT

2019. "Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04105634.

All > Toxicity > Amyloidosis