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Evuzamitide Imaging for Amyloidosis

Phase 2
Recruiting
Led By Mathew Maurer, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
TTR genotype shown to be either Val122Ile or wild type
Left ventricular septal OR inferolateral wall thickness ≥12 mm with echocardiographic features of ATTR-CM (low tissue doppler velocities, preserved apical strain, elevated E/E') or CMR features of an infiltrative cardiomyopathy (increased wall thickness with delayed enhancement or difficulty nulling of the myocardium)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month after scanning
Awards & highlights

Study Summary

This trial will assess if 124I-evuzamitide PET scanning can identify ATTR-CM in patients with heart failure and increased wall thickness not currently diagnosed with ATTR-CM.

Who is the study for?
This trial is for adults with thickened heart walls and signs of cardiac amyloidosis, who can consent to the study. It's not for those with primary or secondary amyloidosis unrelated to transthyretin, pregnant women, patients on certain blood thinners, or anyone with a life expectancy under one year due to other diseases.Check my eligibility
What is being tested?
The trial tests I 124-Evuzamitide as a PET scan imaging agent in detecting cardiac and extra-cardiac amyloid deposits in patients suspected of having ATTR-CM but have inconclusive standard scans. It aims to improve diagnosis accuracy for specific genetic variants associated with this condition.See study design
What are the potential side effects?
Potential side effects are not explicitly listed here; however, as with any PET scan procedure using radiotracers like I 124-Evuzamitide, there may be risks related to radiation exposure and possible allergic reactions to the tracer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My genetic test shows I have the Val122Ile mutation or no mutation.
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My heart has thick walls and signs of a specific type of heart disease.
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I have a grade 1 Tc99-PYP scan with signs of heart amyloidosis or confirmed by biopsy.
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My heart pumps well (EF>40%).
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I have ATTR-CM and signs of amyloidosis outside my heart, like nerve issues or carpal tunnel.
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My tests show amyloid deposits in my heart or other tissues.
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My heart condition allows me to perform daily activities with slight or moderate limitations.
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I had a Tc99-PYP scan for heart issues, but it didn't confirm the condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month after scanning
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month after scanning for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
COV in subjects who are allele carriers with non-diagnostic PYP scans
COV in subjects with ATTR-CM
COV in subjects with heart failure and grade 1 PYP scans

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Subjects with ATTR-CM from either ATTRwt or Val122Ile variant who have biopsy proven evidence of extra-cardiac TTR amyloidosis or clinical suspicion of extracardiac disease, including but not limited to peripheral neuropathy, carpal tunnel syndrome, spinal stenosis will be administered single dose evuzamitide <1mCi.. ATTR-CM defined by the following Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy with 99m Tc-pyrophosphate with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, End-diastolic interventricular septum thickness of > 12 mm on previous echocardiogram TTR genotype shown to be either Val122Ile or wild type.
Group II: Cohort 2Experimental Treatment1 Intervention
Subjects with TTR variant such as Phe64Leu, late onset Val30Met, etc.) that are associated with cardiac amyloidosis but have PYP scans not diagnostic of ATTR-CM will be administered single dose evuzamitide <1mCi. Tc99-PYP scan performed for clinical suspicion of ATTR-CM that is not diagnostic of ATTR-CM No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine. Left ventricular septal OR inferolateral wall thickness ≥12 mm with echocardiographic features of ATTR-CM (low tissue doppler velocities, preserved apical strain, elevated E/E') or CMR features of an infiltrative cardiomyopathy (increased wall thickness with delayed enhancement or difficulty nulling of the myocardium)
Group III: Cohort 1Experimental Treatment1 Intervention
Subjects with grade 1 Tc99-PYP scans who have clinical features suggestive of ATTR-CM or have grade 1 Tc99-PYP scans but endomyocardial biopsy evidence of TTR cardiac amyloidosis will be administered single dose evuzamitide <1mCi. Heart failure with a preserved ejection fraction (EF>40%) Grade 1 Tc99-PYP scan performed for clinical suspicion of ATTR-CM No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine. Left ventricular septal OR inferolateral wall thickness ≥12 mm

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,234 Total Patients Enrolled
5 Trials studying Amyloidosis
2,518 Patients Enrolled for Amyloidosis
Attralus, Inc.Industry Sponsor
6 Previous Clinical Trials
325 Total Patients Enrolled
6 Trials studying Amyloidosis
325 Patients Enrolled for Amyloidosis
Mathew Maurer, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Amyloidosis
15 Patients Enrolled for Amyloidosis

Media Library

Cohort 3 Clinical Trial Eligibility Overview. Trial Name: NCT05635045 — Phase 2
Amyloidosis Research Study Groups: Cohort 3, Cohort 2, Cohort 1
Amyloidosis Clinical Trial 2023: Cohort 3 Highlights & Side Effects. Trial Name: NCT05635045 — Phase 2
Cohort 3 2023 Treatment Timeline for Medical Study. Trial Name: NCT05635045 — Phase 2

Frequently Asked Questions

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

What is the overall enrollment of participants in this experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, posted on December 1st 2022, is currently admitting participants. 25 individuals are sought out from a single location for participation in the study."

Answered by AI

Are participants in this clinical study required to be over the age of 20?

"This study has specific requirements for potential participants, as those aged 50 to 105 are eligible. Additionally, 2 trials have been initiated for individuals under 18 years of age and 97 trials are taking place with patients over 65."

Answered by AI

Are there any openings still available to participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this ongoing medical study is currently seeking volunteers. The trial was initially posted in December 1st 2022 and most recently updated on November 23rd 2022 with the goal of recruiting 25 patients from one site."

Answered by AI

Is it feasible for me to participate in this medical experiment?

"This clinical trial is enrolling 25 individuals who have transthyretin amyloidosis and are between 50 and 105 years of age."

Answered by AI

Is Cohort 1 authorized by the FDA?

"Due to the nature of this Phase 2 trial, lacking evidence for efficacy and having some safety data, Cohort 1 was rated a 2 on our team's scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR
Mathew S. Maurer 2022. "Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05635045.
All > Amyloidosis
~1 spots leftby Jun 2024
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