Cardiac AmyloidosisPhase 3REVEALNCT06788535
REVEAL - Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis
A Phase 3 study testing I-124 evuzamitide in people with Cardiac Amyloidosis, run by Sharmila Dorbala at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- I-124 evuzamitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 20 sitesUnited States
- Study dates
- 14 Jan 2025to 9 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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., echocardiogram [ECHO], cardiac magnetic resonance imaging [CMR], bone-avid tracer cardiac single-photon emission computerized tomography (SPECT), extracardiac biopsy, or endomyocardial biopsy [EMB]). Participants may 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 during the treatment period and for at least 120 days after the last dose of study intervention.
Who cannot join
- Established diagnosis of cardiac amyloidosis.
- Established diagnosis of systemic amyloidosis with known organ involvement (e.g., renal AL or ATTR peripheral neuropathy). Participants who are amyloid positive only from peripheral tissue, such as abdominal fat, carpal tunnel tissue, or laminectomy tissue, 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 amyloidosis: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and they are enrolled in this trial, but they 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 KI.
Show all 13Show fewer
- Receiving hemodialysis or peritoneal dialysis.
- Estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73 m^2.
- Myocardial infarction within 3 months of screening.
- Has severe claustrophobia or any condition, medical 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 7 days prior to I-124 evuzamitide administration.
- Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal thyroxine [T4]).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Cook County Health
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope - Duarte
Duarte, California, 91010
Duke University
Durham, North Carolina, 27710
Cone Health
Greensboro, North Carolina, 27401
Houston Methodist
Houston, Texas, 77030
St. Lukes (CVIT) Saint Luke's Health System
Kansas City, Missouri, 64111
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Rutgers
New Brunswick, New Jersey, 08901
Yale Cardiovascular Medicine
New Haven, Connecticut, 06520
Columbia University
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of California
San Francisco, California, 94143
Mayo Clinic
Scottsdale, Arizona, 85259
Washington University of St. Louis
St Louis, Missouri, 63110
Cleveland Clinic
Weston, Florida, 33331
About this study
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)
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.
Read the detailed description
This multicenter, open-label, single-arm, single-dose study will 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.
The study consists of (i) up to a 45-day screening period, (ii) a treatment emergent period that consists of a 1-day treatment visit and safety follow-up procedures through Day 30 ± 5 days, and (iii) a Standard of Truth (SoT) Diagnostic Evaluation Period that extends from the screening period (Day -45) until either the last cardiac amyloidosis diagnostic test is completed or through Day 60, whichever is earlier. Thus, the total participant duration is up to approximately 3.5 months. The study will enroll approximately 200 participants with suspected cardiac amyloidosis at approximately 20 United States clinical sites.
I-124 evuzamitide is the only study intervention; neither reference therapy nor placebo will be administered. Potassium iodide (KI) will be given orally for 3 days beginning >30 minutes prior to intravenous administration of study intervention. PET/CT scans will be obtained approximately 4 hours after administration of study intervention.
Sensitivity and specificity of I-124 evuzamitide will be determined using the classification of participants based on visual evaluation of the PET/CT images and cardiac amyloid disease status based on the clinical truth standard. An independent Clinical Adjudication Committee with expertise in cardiology, amyloidosis, and/or cardiac imaging will review the information obtained during the diagnostic evaluation (e.g., clinical history and laboratories, EMB, extracardiac biopsy, ECHOs, CMR, and bone-avid tracer cardiac SPECT) to determine if the data support a diagnosis of cardiac amyloidosis. The clinical truth standard will be based on all available information provided to the Clinical Adjudication Committee by the diagnostic evaluation. Three independent readers who are blinded to all clinical data will review deidentified PET/CT images for the presence/absence of cardiac uptake of I-124 evuzamitide.
- Conditions
- Cardiac Amyloidosis
- Being tested
- I-124 evuzamitide
- Keywords
- Amyloid Light Chain (AL), Cardiac Amyloidosis, Amyloidosis, Amyloid Transthyretin (ATTR), Transthyretin (TTR), REVEAL, PET Imaging
- Medical subject headings
- Amyloid Neuropathies, Familial, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-124 evuzamitideDrug
Also called AT-01
A single dose of 1 mCi (± 10%) I-124 evuzamitide administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Single dose, Open label | Experimental | Open label use of I124-evuzamitide to diagnose cardiac amyloidosis. Receives: Drug: I-124 evuzamitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Assessment of the sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Measured: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Assessment of specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
Measured: Up to 60 days after administration of I-124 evuzamitide
Secondary outcomes (6)
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac ATTR amyloidosis
The sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac ATTR amyloidosis based on visual scan interpretation.
Measured: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac ATTR amyloidosis
The specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac ATTR amyloidosis based on visual scan interpretation
Measured: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac AL amyloidosis
The sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac AL amyloidosis based on visual scan interpretation
Measured: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac AL amyloidosis
The specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac AL amyloidosis based on visual scan interpretation
Measured: Up to 60 days after administration of I-124 evuzamitide
To evaluate the safety (treatment-emergent adverse events [AEs]) of a single intravenous administration of I-124 evuzamitide
Incidence of treatment-emergent AEs from Day 1 to Day 30
Measured: Up to 30 days after administration of I-124 evuzamitide
To evaluate the safety (clinical laboratory values) of a single intravenous administration of I-124 evuzamitide
Change from Baseline in clinical laboratory values:
Hematology, Serum Chemistry, Biomarker Assays, Pregnancy Testing
Measured: Up to 30 days after administration of I-124 evuzamitide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start14 Jan 2025
- Primary completion8 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharmila Dorbala
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Sharmila Dorbala, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788535
- Sponsor's protocol ID
- 2024P002136
- Acronym
- REVEAL
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37940323Clerc 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.
PubMed 37676210Dorbala S, Maurer MS, Cuddy SAM, AbouEzzeddine OF, Di Carli MF, Dilsizian V, Dispenzieri A, Gallegos-Kattan C, Guthrie S, Mangal B, Hanna M, Khouri MG, Malhotra S, Mitchell JD, Narra RK, Orlandi C, Rosenthal JL, Ruberg FL, Smiley D, Sperry BW, Udelson JE, Weinberg RL, Wall JS, Masri A; REVEAL Study Investigators. 124I-Evuzamitide Positron Emission Tomography/Computed Tomography for Diagnosing Cardiac Amyloidosis: The REVEAL Nonrandomized Clinical Trial. JAMA. 2026 Aug 30. doi: 10.1001/jama.2026.17361. Online ahead of print.
PubMed 42669054
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06788535
- Acronym / sponsor ID
- REVEAL / 2024P002136
- Conditions
- Cardiac Amyloidosis
- Keywords
- Amyloid Light Chain (AL), Cardiac Amyloidosis, Amyloidosis, Amyloid Transthyretin (ATTR), Transthyretin (TTR), REVEAL, PET Imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Sharmila DorbalaUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 23 Jan 2025 (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.
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.
Detailed description
This multicenter, open-label, single-arm, single-dose study will 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.
The study consists of (i) up to a 45-day screening period, (ii) a treatment emergent period that consists of a 1-day treatment visit and safety follow-up procedures through Day 30 ± 5 days, and (iii) a Standard of Truth (SoT) Diagnostic Evaluation Period that extends from the screening period (Day -45) until either the last cardiac amyloidosis diagnostic test is completed or through Day 60, whichever is earlier. Thus, the total participant duration is up to approximately 3.5 months. The study will enroll approximately 200 participants with suspected cardiac amyloidosis at approximately 20 United States clinical sites.
I-124 evuzamitide is the only study intervention; neither reference therapy nor placebo will be administered. Potassium iodide (KI) will be given orally for 3 days beginning >30 minutes prior to intravenous administration of study intervention. PET/CT scans will be obtained approximately 4 hours after administration of study intervention.
Sensitivity and specificity of I-124 evuzamitide will be determined using the classification of participants based on visual evaluation of the PET/CT images and cardiac amyloid disease status based on the clinical truth standard. An independent Clinical Adjudication Committee with expertise in cardiology, amyloidosis, and/or cardiac imaging will review the information obtained during the diagnostic evaluation (e.g., clinical history and laboratories, EMB, extracardiac biopsy, ECHOs, CMR, and bone-avid tracer cardiac SPECT) to determine if the data support a diagnosis of cardiac amyloidosis. The clinical truth standard will be based on all available information provided to the Clinical Adjudication Committee by the diagnostic evaluation. Three independent readers who are blinded to all clinical data will review deidentified PET/CT images for the presence/absence of cardiac uptake of I-124 evuzamitide.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose, Open label | Experimental | Drug: I-124 evuzamitideOpen label use of I124-evuzamitide to diagnose cardiac amyloidosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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., echocardiogram [ECHO], cardiac magnetic resonance imaging [CMR], bone-avid tracer cardiac single-photon emission computerized tomography (SPECT), extracardiac biopsy, or endomyocardial biopsy [EMB]). Participants may 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.
Key exclusion criteria (13 listed)
- Established diagnosis of cardiac amyloidosis.
- Established diagnosis of systemic amyloidosis with known organ involvement (e.g., renal AL or ATTR peripheral neuropathy). Participants who are amyloid positive only from peripheral tissue, such as abdominal fat, carpal tunnel tissue, or laminectomy tissue, 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 amyloidosis: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and they are enrolled in this trial, but they 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.
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 |
|---|---|---|
| I-124 evuzamitideAlso: AT-01A single dose of 1 mCi (± 10%) I-124 evuzamitide administered intravenously. | Drug | Single dose, Open label |
Primary outcome
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
Assessment of the sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac amyloidosis
Time frame: Up to 60 days after administration of I-124 evuzamitide
Assessment of specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.
6 secondary outcomes
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac ATTR amyloidosis
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac ATTR amyloidosis
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (sensitivity) of I-124 evuzamitide for diagnosing cardiac AL amyloidosis
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the efficacy (specificity) of I-124 evuzamitide for diagnosing cardiac AL amyloidosis
Time frame: Up to 60 days after administration of I-124 evuzamitide
To evaluate the safety (treatment-emergent adverse events [AEs]) of a single intravenous administration of I-124 evuzamitide
Time frame: Up to 30 days after administration of I-124 evuzamitide
To evaluate the safety (clinical laboratory values) of a single intravenous administration of I-124 evuzamitide
Time frame: Up to 30 days after administration of I-124 evuzamitide
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 37940323Wall 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.
- Background: PubMed 37676210Clerc 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.
- Derived from this study: PubMed 42669054Dorbala S, Maurer MS, Cuddy SAM, AbouEzzeddine OF, Di Carli MF, Dilsizian V, Dispenzieri A, Gallegos-Kattan C, Guthrie S, Mangal B, Hanna M, Khouri MG, Malhotra S, Mitchell JD, Narra RK, Orlandi C, Rosenthal JL, Ruberg FL, Smiley D, Sperry BW, Udelson JE, Weinberg RL, Wall JS, Masri A; REVEAL Study Investigators. 124I-Evuzamitide Positron Emission Tomography/Computed Tomography for Diagnosing Cardiac Amyloidosis: The REVEAL Nonrandomized Clinical Trial. JAMA. 2026 Aug 30. doi: 10.1001/jama.2026.17361. 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing I-124 evuzamitide in people with Cardiac Amyloidosis, run by Sharmila Dorbala at 20 sites 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 30 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 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. 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 NCT06788535, which also lists 3 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 30 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.