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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

Must not have

Patients on dialysis or those with eGFR <30 cc/min/1.73 m2

Received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline scan

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis or my kidney function is very low.

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I have taken heparin or similar medications within the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline scan

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

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

Primary study objectives

Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution

Secondary study objectives

Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met