PET/CT Imaging in Carriers of TTR Mutations (NCT07591038) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PET/CT Imaging in Carriers of TTR Mutations
United States80 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
A. Pathogenic TTR Allele Carriers without HF
Inclusion:
* 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
Exclusion:
* 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):
Inclusion:
* men and women ages 30-80 who have symptomatic V122I hATTR-CA as determined by a history of HF (this will be assessed by study per…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses PET/CT imaging to measure how much of an injected dose shows up in the heart — could this type of scan help give us a clearer picture of how amyloid is affecting my heart compared to the tests I've already had?
2Since the trial is listed as 'not yet recruiting,' do you know when it might open and whether it would make sense for us to wait for it or pursue other diagnostic options in the meantime?
3This study focuses on people who carry TTR mutations — given my specific mutation, do you think I would likely be a candidate worth discussing with the research team once enrollment opens?
4Because this appears to be an imaging study rather than a treatment trial, what would actually happen to me as a participant — would I receive any scans or information that could directly influence my care plan?
5Are there standard imaging tests already available, like a DPD or pyrophosphate scan, that could give us similar information now, or is there a reason this PET/CT approach might offer something those tests don't?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
LV % Injected dose
Timeframe: PET/CT Scan Visit
Trial details
NCT IDNCT07591038
SponsorUniversity of Texas Southwestern Medical Center