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

Primary Purpose

Amyloidosis, Transthyretin Amyloidosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
124I-Evuzamitide
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyloidosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Patient willing to consent for the study and undergo the study procedures. Exclusion Criteria: Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol Has a known allergy to potassium iodide treatment or to gadolinium. Patients on dialysis or those with eGFR <30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration

Sites / Locations

  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with ATTR-CM

Arm Description

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.

Outcomes

Primary Outcome Measures

Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution
Pearson Correlation Coefficient of ECV (%) and SUV (124I-Evuzamitide) globally and at a per segment basis

Secondary Outcome Measures

Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake
Pearson Correlation Coefficient of stage of amyloidosis (Mayo Staging System) and SUV (124I-Evuzamitide)
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 liver and spleen ECV and their respective 124I-Evuzamitide uptake
Proportion of patients with ATTR-CM and MGUS or smoldering myeloma who are correctly classified as ATTR-CM based on 124I-Evuzamitide distribution and uptake

Full Information

First Posted
January 25, 2023
Last Updated
February 24, 2023
Sponsor
Oregon Health and Science University
Collaborators
Attralus, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05758493
Brief Title
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Official Title
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
April 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Attralus, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis, Transthyretin Amyloidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with ATTR-CM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
124I-Evuzamitide
Other Intervention Name(s)
AT-01
Intervention Description
Amyloid reactive protein used as imaging agent to detect systemic amyloidosis
Primary Outcome Measure Information:
Title
Correlation between ECV and 124I-Evuzamitide cardiac uptake and distribution
Description
Pearson Correlation Coefficient of ECV (%) and SUV (124I-Evuzamitide) globally and at a per segment basis
Time Frame
At baseline scan
Secondary Outcome Measure Information:
Title
Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake
Description
Pearson Correlation Coefficient of stage of amyloidosis (Mayo Staging System) and SUV (124I-Evuzamitide)
Time Frame
At baseline scan
Title
Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide
Time Frame
During baseline scan and follow up scan
Title
Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake
Time Frame
During baseline scan and follow up scan
Title
Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake
Time Frame
During baseline scan and follow up scan
Title
Proportion of patients with ATTR-CM and MGUS or smoldering myeloma who are correctly classified as ATTR-CM based on 124I-Evuzamitide distribution and uptake
Time Frame
During baseline scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Patient willing to consent for the study and undergo the study procedures. Exclusion Criteria: Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol Has a known allergy to potassium iodide treatment or to gadolinium. Patients on dialysis or those with eGFR <30 cc/min/1.73 m2 will be excluded from undergoing gadolinium-enhanced cardiac MRI. Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to 124I-Evuzumitide administration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Masri, MD
Phone
503-418-1964
Email
masria@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Cardin, MS PhD
Phone
503-418-1964
Email
cardin@ohsu.edu
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Masri, MD
Email
masria@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Ahmad Masri, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34786667
Citation
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.
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Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis

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