RECRUITING

Research with I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Conditions

Cardiac Amyloidosis Amyloid Light Chain (AL)Amyloidosis Amyloid Transthyretin (ATTR)Transthyretin (TTR)REVEAL PET Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2025-01-14

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06788535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 willing to 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	* 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 medical condition that would prevent completion of the imaging protocol. * 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).

Inclusion Criteria

Exclusion 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 willing to 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

* 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 medical condition that would prevent completion of the imaging protocol.
* 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).

Contacts and Locations

Study Contact

Sharmila Dorbala, MD, MPH, MASNC

CONTACT

6177326290

sdorbala@bwh.harvard.edu

Alyssa de Moraes, MS

CONTACT

617-732-6647

Principal Investigator

Sharmila Dorbala, MD, MPH, MASNC

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Sharmila Dorbala

Sharmila Dorbala, MD, MPH, MASNC, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-14

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-01-14

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Amyloid Light Chain (AL)
Cardiac Amyloidosis
Amyloidosis
Amyloid Transthyretin (ATTR)
Transthyretin (TTR)
REVEAL
PET Imaging

Additional Relevant MeSH Terms

Cardiac Amyloidosis