PET/CT Imaging in Carriers of TTR Mutations
EPIC-TTR
Iodine-124 Evuzamitide PET/CT Imaging in Carriers of TTR Mutations
2 other identifiers
observational
80
1 country
1
Brief Summary
The purpose of this study is to determine if TTR gene carriers have early signs of a type of heart disease called amyloidosis using a new radiotracer dye (iodine-124 evuzamitide, I-124E). Participants will undergo a screening that includes a medical history review and completion of quality-of-life surveys. Once screening is complete, participants will undergo an imaging test called a positron emission tomography (PET) scan combined with computed tomography (PET/CT) to make images of the body. The new radiotracer dye (I-124E, a radioactive contrast) will be used during the PET/CT to make amyloidosis visible in the heart and body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
Study Completion
Last participant's last visit for all outcomes
June 30, 2030
May 19, 2026
May 1, 2026
3.9 years
May 8, 2026
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LV % Injected dose
Evidence of subclinical cardiac amyloid infiltration as measured by PET/CT quantification imaging with I-124E. This will be defined as LV % injected dose (LV%ID = volume of interest \[VOI\] mean activity concentration in the LV X VOI volume / injected activity). LV%ID is an ideal metric to assess cardiac amyloid burden because it is: 1) correlated with validated metrics assessing cardiac amyloid burden; 2) sensitive for detection of early disease (patchy vs. diffuse uptake); and 3) highly repeatable and standardizable to other metrics of radiotracer uptake. LV%ID is adjusted for injected activity, but not for body weight, because the latter is unnecessary for a radiotracer accumulating in the heart and specific organs, not in the whole body.
PET/CT Scan Visit
Secondary Outcomes (16)
LVFW SUVR, mean
PET/CT Scan Visit
LVFW wall SUVR, max
PET/CT Scan Visit
IVS SUVR, mean
PET/CT Scan Visit
IVS SUVR, max
PET/CT Scan Visit
RVFW SUVR, mean
PET/CT Scan Visit
- +11 more secondary outcomes
Study Arms (3)
Pathogenic TTR Allele Carriers without Heart Failure
Subjects with Symptomatic ATTR-CA
Non-carrier race-matched controls
Interventions
I-124E is a novel amyloidophilic peptide radiotracer that binds via electrostatic interactions to electronegative glycosaminoglycans and amyloid protein fibrils - both are ubiquitous among amyloid deposits. PET/CT I-124E has acceptable dosimetry estimates and is acceptable for whole-body PET/CT imaging. Data from patients with amyloidosis has established that tracer uptake is present in locations of clinically anticipated amyloid deposits and in locations not clinically appreciated, but also consistent with the distribution of amyloid in the human body (e.g. heart, kidney, spleen).
Eligibility Criteria
We will enroll 50 carriers of pathogenic TTR alleles without HF, 20 patients with ATTR-CA, and 10-race matched non-carrier controls to have PET/CT I-124E imaging.
You may qualify if:
- men and women ages 30-80 who are pathogenic allele TTR carriers without history of HF (this will be assessed by study personnel and defined as : 1) No history of hospitalization within the previous 12 months for management of HF; 2) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
- have already completed the protocol for NCT05489549 at UT Southwestern only
You may not qualify if:
- a self-reported history or clinical history of HF
- other known causes of cardiomyopathy
- history of light-chain cardiac amyloidosis
- prior type 1 myocardial infarction
- cardiac transplantation
- liver transplantation
- body weight or habitus that exceeds the site-specific PET/CT parameters
- estimated glomerular filtration rate ≤30 mL/min/1.73 m2
- inability to safely undergo PET/CT
- participating in a clinical trial for ATTR treatments or taking a fibril deleting agent
- pregnancy or breastfeeding
- patients taking heparin or heparin derivatives for anticoagulation
- allergy to potassium iodide
- known uncorrected thyroid disorder
- B. Subjects with symptomatic hATTR-CA (may be supplemented with other ATTR-CA genotypes including wild-type in the occasion of slow enrollment):
- +34 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Bayercollaborator
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75248, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin L Grodin, MD MPH
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 8, 2026
First Posted
May 15, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share