Clinical trial NCT06788535: Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis
Official title: A Phase 3, Open-Label, Multicenter Study of I-124 Evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis Using Positron Emission Tomography Computed Tomography (PET/CT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiac Amyloidosis
Keywords: Amyloid Light Chain (AL)
Cardiac Amyloidosis
Amyloidosis
Amyloid Transthyretin (ATTR)
Transthyretin (TTR)
REVEAL
PET Imaging
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Attralus, Inc.
First posted: 2025-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this Phase 3, open label, single dose imaging study is to evaluate the efficacy and safety of I-124 evuzamitide (radioactive dye) for diagnosing Cardiac Amyloidosis in participants with suspected Cardiac Amyloidosis. The imaging test that will be used in this study is a Positron Emission Tomography Computed Tomography (PET/CT) scan.

Detailed description: This Phase 3, open label, single dose study will evaluate the efficacy and safety of I-124 evuzamitide when administered as a single dose prior to a PET/CT scan. Participants will be in the study for up to 60 days and approximately 200 participants with suspected Cardiac Amyloidosis will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Understands the study procedures and can give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Male or female ≥18 years of age.
* Is suspected of having cardiac amyloidosis and is undergoing or will undergo a diagnostic evaluation for cardiac amyloidosis (e.g., echocardiography, CMR, bone avid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.). Participants can be enrolled before or during their diagnostic evaluation for cardiac amyloidosis.
* Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 30 days after administration of I-124 evuzamitide.
* For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

Exclusion Criteria:

* Established diagnosis of cardiac amyloidosis.
* Established diagnosis of systemic amyloidosis (e.g., renal AL or ATTR peripheral neuropathy) without known cardiac involvement. Participants who are amyloid positive only with carpal tunnel tissue or laminectomy are allowed as long as they do not have other known organ involvement.
* Receiving therapy with an approved treatment (e.g., tafamadis) or in a clinical trial for treatment for ATTR cardiac amyloidosis at time of enrollment. For AL and ATTR: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and participant is enrolled in this trial but may not receive an experimental therapy until after the Day 30 safety follow-up visit in this trial.
* Is pregnant or breast-feeding.
* Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
* Has a known allergy to potassium iodide.
* Receiving hemodialysis or peritoneal dialysis.
* eGFR less than 15mL/min/1.73m2.
* Myocardial infarction within three (3) months of screening.
* Has severe claustrophobia or any condition, medial or otherwise, that would prevent completion of the study assessments.
* Has any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the participant.
* Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within seven (7) days prior to I-124 evuzamitide administration.
* Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal T4).

Primary outcomes:
measure: To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis-Sensitivity
timeFrame: Up to 60 days after scanning
measure: To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis-Specificity
timeFrame: Up to 60 days after scanning
Secondary outcomes:
measure: To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Treatment Emergent Adverse Events
timeFrame: 30 days after administration of I-124 evuzamitide
measure: To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Creatinine
timeFrame: 30 days after administration of I-124 evuzamitide
measure: To evaluate the safety of a single intravenous administration of I-124 evuzamitide-eGFR
timeFrame: 30 days after administration of I-124 evuzamitide
measure: To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Liver function.
timeFrame: 30 days after administration of I-124 evuzamitide
measure: To evaluate the safety of a single intravenous administration of I-124 evuzamitide.
timeFrame: 30 days after administration of I-124 evuzamitide
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Duarte
country: United States
facility: City of Hope - Duarte
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: New Haven
country: United States
facility: Yale Cardiovascular Medicine
state: Connecticut
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Lukes (CVIT) Saint Luke's Health System
state: Missouri
city: St. Louis
country: United States
facility: Washington University of St. Louis
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
citation: Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.
citation: Clerc OF, Cuddy SAM, Robertson M, Vijayakumar S, Neri JC, Chemburkar V, Kijewski MF, Di Carli MF, Bianchi G, Falk RH, Dorbala S. Cardiac Amyloid Quantification Using 124I-Evuzamitide (124I-P5+14) Versus 18F-Florbetapir: A Pilot PET/CT Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1419-1432. doi: 10.1016/j.jcmg.2023.07.007. Epub 2023 Sep 6.