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124I-Evuzamitide for Amyloidosis

Phase 2
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who are carriers of a known pathogenic mutation in the transthyretin gene
Subjects with systemic amyloidosis with known organ involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during baseline scan
Awards & highlights

Study Summary

This trial looks at how a new drug affects people with systemic amyloidosis, by tracking its distribution and how it affects organs like the heart. Patients will have MRI and CT scans to measure changes.

Who is the study for?
This trial is for people with systemic amyloidosis, specifically those who have a mutation in the transthyretin gene and known organ involvement. It's also open to patients with multiple myeloma or monoclonal gammopathy of undetermined significance. People can't join if they're allergic to potassium iodide or gadolinium, have severe kidney issues, recently used heparin products, or can't complete imaging procedures due to claustrophobia or other conditions.Check my eligibility
What is being tested?
The study is testing how well Iodine-124 Evuzumitide (AT-01) shows up in different organs of patients with amyloidosis using advanced imaging techniques like PET/MRI scans. Some may get PET/CT scans instead. The goal is to see where the drug goes in the body and how it relates to heart structure and function over time.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than treatment effects, side effects are related primarily to the imaging agent Iodine-124 Evuzumitide itself which could include allergic reactions. Imaging procedures carry their own risks such as exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I carry a mutation in the transthyretin gene.
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I have amyloidosis affecting my organs.
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I have been diagnosed with a condition where abnormal proteins are in my blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution
Secondary outcome measures
Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide
Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake
Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with ATTR-CMExperimental Treatment1 Intervention
Patients with ATTR-CM will undergo hybrid 124I-Evuzamitide PET/MRI imaging (or PET/CT) at baseline and in a subgroup, repeat imaging will be performed at an interval of 6-12 months.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,882 Total Patients Enrolled
2 Trials studying Amyloidosis
104 Patients Enrolled for Amyloidosis
Attralus, Inc.Industry Sponsor
6 Previous Clinical Trials
320 Total Patients Enrolled
6 Trials studying Amyloidosis
320 Patients Enrolled for Amyloidosis

Media Library

Patients with ATTR-CM Clinical Trial Eligibility Overview. Trial Name: NCT05758493 — Phase 2
Amyloidosis Research Study Groups: Patients with ATTR-CM
Amyloidosis Clinical Trial 2023: Patients with ATTR-CM Highlights & Side Effects. Trial Name: NCT05758493 — Phase 2
Patients with ATTR-CM 2023 Treatment Timeline for Medical Study. Trial Name: NCT05758493 — Phase 2

Frequently Asked Questions

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

Does this study accommodate individuals aged 70 and above?

"This research project is looking for participants aged 18 and above, up to the age of 90."

Answered by AI

Is it possible for me to enroll in this research project?

"Potential participants in this amyloidosis-focused clinical trial are required to be between 18 and 90 years of age. However, only a maximum of 30 enrollees will be accepted into the study."

Answered by AI

How hazardous is it for those with ATTR-CM to go untreated?

"The safety profile of ATTR-CM patients was rated a 2, which is justified by the existing Phase 2 data suggesting safety but lacking proof for efficacy."

Answered by AI

Is this research open to new participants?

"Clinicaltrials.gov confirms that this experiment is in need of participants, which was initially posted on January 10th 2023 and most recently updated February 24th 2023."

Answered by AI

What is the participant capacity for this clinical experimentation?

"Affirmative. As demonstrated on clinicaltrials.gov, this medical experiment is presently recruiting patients. It was initially posted on January 10th 2023 and has been revised most recently as of February 24th 2023. 30 subjects are sought from a single location for the study's duration."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
2023. "Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05758493.
All > Al Amyloidosis > Amyloidosis
~13 spots leftby Apr 2025
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