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PET/CT Imaging in Carriers of TTR Mutations (EPIC-TTR)

15 maggio 2026 aggiornato da: Justin Grodin, University of Texas Southwestern Medical Center

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This will be a cross-sectional cohort study of 50 carriers of pathogenic TTR alleles without HF; 10-race matched non-carrier controls; and 20 patients with ATTR-CA. Participants will undergo standardized, PET/CT direct amyloid imaging assessments with I-124E to test the hypothesis that carriers of pathogenic TTR alleles without HF will have LV%ID intermediate to non-carrier controls and patients with ATTR-CA. This will address the fundamental questions of whether and to what extent cardiac amyloid infiltration is present in carriers of pathogenic TTR alleles prior to ATTR-CA disease onset.

Tipo di studio

Osservativo

Iscrizione (Stimato)

80

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Texas
      • Dallas, Texas, Stati Uniti, 75248
        • UT Southwestern Medical Center
        • Investigatore principale:
          • Justin L Grodin, MD MPH
        • Sub-investigatore:
          • Lori Roth, PA-C
        • Contatto:
        • Sub-investigatore:
          • Vlad Zaha, MD PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Pathogenic TTR Allele Carriers without Heart Failure
Test diagnostico: 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).
Subjects with Symptomatic ATTR-CA
Test diagnostico: 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).
Non-carrier race-matched controls
Test diagnostico: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
LV % Injected dose
Lasso di tempo: PET/CT Scan Visit
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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
LVFW SUVR, mean
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
LVFW wall SUVR, max
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
IVS SUVR, mean
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
IVS SUVR, max
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
RVFW SUVR, mean
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
RVFW SUVR, max
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
RV % Injected Dose (RV%ID)
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
LV Cardiac Amyloid Activity (CAA)
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
LV Target-to-Background Ratio (TBR)
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
RV Cardiac Amyloid Activity (CAA)
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
RV Target-to-Background Ratio (TBR)
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
Left Atrial Uptake
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
Right Atrial Uptake
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
Liver Uptake
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
Spleen Uptake
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit
Kidney Uptake
Lasso di tempo: PET/CT Scan Visit
PET/CT Scan Visit

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Texas Southwestern Medical Center

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)
Bayer

Investigatori

  • Investigatore principale: Justin L Grodin, MD MPH, University of Texas Southwestern Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 giugno 2030

Completamento dello studio (Stimato)

30 giugno 2030

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

15 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STU-2026-0286
  • R01HL172993 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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