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NCT07591038

PET/CT Imaging in Carriers of TTR Mutations

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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.

Official title: Iodine-124 Evuzamitide PET/CT Imaging in Carriers of TTR Mutations

Key Details

Gender

All

Age Range

30 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2030-06-30

Last Updated

2026-05-19

Healthy Volunteers

Yes

Conditions

ATTR ATTR Gene Mutation Cardiomyopathy Transthyretin Mediated Amyloidosis (ATTR)

Interventions

DIAGNOSTIC_TEST

Iodine-124 Evuzamitide (I-124E)

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).

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 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 C. 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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States