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

15. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

80

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75248
        • UT Southwestern Medical Center
        • Hauptermittler:
          • Justin L Grodin, MD MPH
        • Unterermittler:
          • Lori Roth, PA-C
        • Kontakt:
        • Unterermittler:
          • Vlad Zaha, MD PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Pathogenic TTR Allele Carriers without Heart Failure
Diagnosetest: 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
Diagnosetest: 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
Diagnosetest: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
LV % Injected dose
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Texas Southwestern Medical Center

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

30. Juni 2030

Studienabschluss (Geschätzt)

30. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

8. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STU-2026-0286
  • R01HL172993 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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