AmyloidosisPhase 2NCT05758493
Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
A Phase 2 study testing 124I-Evuzamitide in people with Amyloidosis and Transthyretin Amyloidosis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Amyloidosis, Transthyretin Amyloidosis
- What is being tested?
- 124I-Evuzamitide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 10 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Ahmad Masri, MD, masria@ohsu.edu
Ahmad Masri, MD
About this study
This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 4) 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.
- Conditions
- Amyloidosis, Transthyretin Amyloidosis
- Being tested
- 124I-Evuzamitide
- Medical subject headings
- Amyloidosis, Amyloidosis, Hereditary, Transthyretin-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-EvuzamitideDiagnostic test
Also called AT-01
Amyloid reactive protein used as imaging agent to detect systemic amyloidosis
| Study group | Role | What they receive |
|---|---|---|
| Patients with ATTR-CM | Experimental | 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. Receives: Diagnostic Test: 124I-Evuzamitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-124 evuzamitide diagnostic accuracy
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, compared to SoC site diagnosis. We will assess:
- The sensitivity of PET/MRI with 124I-evuzamitide PET/MRI for the diagnosis of cardiac amyloidosis.
- The specificity of PET/MRI with 124I-evuzamitide for the diagnosis of cardiac amyloidosis.
Measured: At baseline scan
Secondary outcomes (7)
Quantitative measures
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on quantitative scan interpretation, compared to SoC site diagnosis. We will assess the sensitivity and specificity of various quantitative measures, and evaluate inter- and intra-reader agreement.
Measured: At baseline scan
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)
Measured: At baseline scan
Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide
Measured: During baseline scan and follow up scan
Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake
Measured: During baseline scan and follow up scan
Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake
Measured: During baseline scan and follow up scan
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
Measured: During baseline scan
To evaluate the safety of a single intravenous administration of I-124 evuzamitide.
Incidence of related treatment-emergent (S)AEs from time of study drug administration to Day 7
Measured: 7 days from baseline scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start10 Jan 2023
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Attralus, Inc., Bayer
- Responsible party
- Principal investigator, Ahmad Masri, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758493
- Sponsor's protocol ID
- 24299
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34786667Masri A, Jahan I, Gillan D, Alqabani M, Suits A, Davis B, Mejia AT, Raposo H, Ferencik M, Medvedova E, Mallak N. 124Iodine Evuzamitide Positron Emission Tomography in Patients With Established or Suspected Cardiac Amyloidosis. JACC Cardiovasc Imaging. 2026 Aug 30:S1936-878X(26)00439-0. doi: 10.1016/j.jcmg.2026.08.005. Online ahead of print.
PubMed 42670739
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT05758493
- Acronym / sponsor ID
- 24299
- Conditions
- Amyloidosis, Transthyretin Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Attralus, Inc., Bayer
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center prospective study evaluating 124I-evuzumitide in patients with systemic amyloidosis. The purpose of this study is to 1) Establish the diagnostic accuracy of 124I-evuzumitide in cardiac amyloidosis 2) Evaluate extracardiac uptake 3) identify and characterize the distribution and uptake of 124I-evuzumitide in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and 4) 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ATTR-CM | Experimental | Diagnostic Test: 124I-EvuzamitidePatients 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 124I-EvuzamitideAlso: AT-01Amyloid reactive protein used as imaging agent to detect systemic amyloidosis | Diagnostic test | Patients with ATTR-CM |
Primary outcome
I-124 evuzamitide diagnostic accuracy
Time frame: At baseline scan
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, compared to SoC site diagnosis. We will assess: * The sensitivity of PET/MRI with 124I-evuzamitide PET/MRI for the diagnosis of cardiac amyloidosis. * The specificity of PET/MRI with 124I-evuzamitide for the diagnosis of cardiac amyloidosis.
7 secondary outcomes
Quantitative measures
Time frame: At baseline scan
Correlation between clinical cardiac biomarkers (i.e. stage of amyloidosis) and myocardial 124I-Evuzamitide uptake
Time frame: At baseline scan
Correlation between Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) and myocardial 124I-Evuzamitide
Time frame: During baseline scan and follow up scan
Correlation between New York Heart Association (NYHA) class and 124I-Evuzamitide uptake
Time frame: During baseline scan and follow up scan
Correlation between liver and spleen ECV and their respective 124I-Evuzamitide uptake
Time frame: During baseline scan and follow up scan
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
To evaluate the safety of a single intravenous administration of I-124 evuzamitide.
Time frame: 7 days from baseline scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 34786667Wall 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.
- Derived from this study: PubMed 42670739Masri A, Jahan I, Gillan D, Alqabani M, Suits A, Davis B, Mejia AT, Raposo H, Ferencik M, Medvedova E, Mallak N. 124Iodine Evuzamitide Positron Emission Tomography in Patients With Established or Suspected Cardiac Amyloidosis. JACC Cardiovasc Imaging. 2026 Aug 30:S1936-878X(26)00439-0. doi: 10.1016/j.jcmg.2026.08.005. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 124I-Evuzamitide in people with Amyloidosis and Transthyretin Amyloidosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Masri, MD (503-418-1964, masria@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-124 evuzamitide diagnostic accuracy (time frame: At baseline scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758493, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.