REVEAL - Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Sharmila Dorbala
Study ID
NCT06788535
Phase
PHASE3
Status
Completed

Conditions

  • Cardiac Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • I-124 evuzamitide — DRUG
    A single dose of 1 mCi (± 10%) I-124 evuzamitide administered intravenously.

Study Details

The purpose of this multicenter, open-label, single-arm, single-dose study is to assess the sensitivity and specificity of I-124 evuzamitide for the diagnosis of cardiac amyloidosis compared to current clinical standards for diagnosis of cardiac amyloidosis. Participants will receive a positron emission tomography computed tomography (PET/CT) scan 4 hours (± 60 minutes) after administration of I-124 evuzamitide. The primary study hypotheses are that the sensitivity and specificity of I-124 evuzamitide PET/CT imaging of cardiac amyloidosis will be greater than 65% and 55%, respectively, in participants with suspected cardiac amyloidosis.

Key Dates

Start date
Jan 14, 2025
Status verified
Apr 2026
Primary completion
Apr 8, 2026
Completion
Apr 9, 2026

Study Design

Enrollment
204 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single dose, Open label
    Open label use of I124-evuzamitide to diagnose cardiac amyloidosis.

Primary Outcome Measure

To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac amyloidosis [ Time Frame: Up to 60 days after administration of I-124 evuzamitide ]

Locations (20)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259-
City of Hope - DuarteDuarteCalifornia91010-
University of CaliforniaSan FranciscoCalifornia94143-
Yale Cardiovascular MedicineNew HavenConnecticut06520-
Cleveland ClinicWestonFlorida33331-
Cook County HealthChicagoIllinois60612-
Northwestern UniversityChicagoIllinois60611-
Brigham and Women's HospitalBostonMassachusetts02115-
Mayo ClinicRochesterMinnesota55905-
St. Lukes (CVIT) Saint Luke's Health SystemKansas CityMissouri64111-
Washington University of St. LouisSt LouisMissouri63110-
RutgersNew BrunswickNew Jersey08901-
Columbia UniversityNew YorkNew York10032-
Duke UniversityDurhamNorth Carolina27710-
Cone HealthGreensboroNorth Carolina27401-
Cleveland ClinicClevelandOhio44195-
Oregon Health and Science UniversityPortlandOregon97239-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Houston MethodistHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic· Scottsdale, AZCity of Hope - Duarte· Duarte, CAUniversity of California· San Francisco, CAYale Cardiovascular Medicine· New Haven, CTCleveland Clinic· Weston, FLCook County Health· Chicago, IL

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