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Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis

NCT ID: NCT05758493

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2028-03-10

Brief Summary

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This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1)identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 2) Correlate the uptake with the structure and function of different organs, including the heart. To achieve these goals, eligible patients will undergo primarily hybrid positron emission tomography and magnetic resonance imaging (PET/MRI). In a subgroup of patients who are unable to undergo PET/MR, computed tomography will be used instead of MRI (i.e. PET/CT). In a subgroup of patients, repeat imaging with the same modality will be done at a interval of 6-12 months. Clinically available data (demographics, phenotype, imaging, laboratory) will also be collected to characterize the disease in each patient.

Detailed Description

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Conditions

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Amyloidosis Transthyretin Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with ATTR-CM

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.

Group Type EXPERIMENTAL

124I-Evuzamitide

Intervention Type DIAGNOSTIC_TEST

Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Interventions

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124I-Evuzamitide

Amyloid reactive protein used as imaging agent to detect systemic amyloidosis

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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AT-01

Eligibility Criteria

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Inclusion Criteria

1. Subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance
2. Patient willing to consent for the study and undergo the study procedures.

Exclusion Criteria

1. Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol
2. Has a known allergy to potassium iodide treatment or to gadolinium.
3. Patients on dialysis or those with eGFR \<30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI.
4. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attralus, Inc.

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Masri

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ahmad Masri, MD

Role: CONTACT

Phone: 503-418-1964

Email: [email protected]

Facility Contacts

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Ahmad Masri, MD

Role: primary

References

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Wall JS, Martin EB, Endsley A, Stuckey AC, Williams AD, Powell D, Whittle B, Hall S, Lambeth TR, Julian RR, Stabin M, Lands RH, Kennel SJ. First in Human Evaluation and Dosimetry Calculations for Peptide 124I-p5+14-a Novel Radiotracer for the Detection of Systemic Amyloidosis Using PET/CT Imaging. Mol Imaging Biol. 2022 Jun;24(3):479-488. doi: 10.1007/s11307-021-01681-2. Epub 2021 Nov 16.

Reference Type BACKGROUND
PMID: 34786667 (View on PubMed)

Other Identifiers

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24299

Identifier Type: -

Identifier Source: org_study_id