NCT07591038Toborzás még nem indult
PET/CT Imaging in Carriers of TTR Mutations
Iodine-124 Evuzamitide PET/CT Imaging in Carriers of TTR Mutations
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 80 (tervezett)
- Első benyújtás
- 2026. máj. 8.
- Kezdés
- 2026. nov. 14.
- Elsődleges befejezés
- 2030. jún. 30.
- Fő szponzor
- University of Texas Southwestern Medical Center
- Betegségek
- Amiloidózis
- NCT-szám
- NCT07591038
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 80
- 2026. nov. 14. és az elsődleges befejezés (2030. jún. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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A regiszterben nem jelölt feltételek
- 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
Életkor a regiszterben: 30 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Egyesült Államok | Ismeretlen állapot |
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