Scanning for early heart amyloidosis in people carrying TTR gene mutations
Tests iodine-124 evuzamitide PET/CT scans for early heart amyloidosis in TTR mutation carriers.
Plain-language title generated from the registry record
Registry title: PET/CT Imaging in Carriers of TTR Mutations
Key facts
- Where
- Dallas, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Source: NCT07591038, who can take part
Where in United States
- UT Southwestern Medical CenterDallas, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Texas Southwestern Medical Center
- Trial code
- NCT07591038
- Record updated
- 29 October 2026
- Original description
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).Read full original descriptionShow less
Iodine-124 Evuzamitide PET/CT Imaging in Carriers of TTR Mutations
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.
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; 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 personnel and defined as : 1) history of hospitalization within the previous 12 months for management of HF; 2) 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); hATTR-CA previously diagnosed histologically by amyloid staining and tissue typing with immunohistochemistry or mass spectrometry or by bone scintigraphy in without abnormal M-protein; TTR gene sequencing confirming the TTR variant; have already completed the protocol for NCT05489549 at UT Southwestern only; Exclusion:; other known causes of cardiomyopathy; history of light-chain cardiac amyloidosis; cardiac transplantation; liver transplantation; history of type I myocardial infarction; 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; patients taking heparin or heparin derivatives for anticoagulation; pregnancy or breastfeeding; allergy to potassium iodide; known uncorrected thyroid disorder; Non-carrier race-matched controls:; Inclusion:; men and women ages 30-80 who are non-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) No clinical diagnosis of HF from a treating clinician; have previously enrolled in the Dallas Heart Study; 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; patients taking heparin or heparin derivatives for anticoagulation; pregnancy or breastfeeding; allergy to potassium iodide; known uncorrected thyroid disorder.