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NCT07591038 · ClinicalTrials.gov registry record
PET/CT Imaging in Carriers of TTR Mutations
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Not yet
- Registry status
- 80
- Enrollment target
NCT07591038: Clinical Trial study, sponsored by University of Texas Southwestern Medical Center.
NCT07591038 is a clinical trial that has not yet begun recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07591038 has not yet begun recruiting, sponsored by University of Texas Southwestern Medical Center.
- NOT YET RECRUITING
- Registry status
- 80 participants
- Enrollment target
Study 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.
Primary Outcome
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 repeat
Interventions
- DIAGNOSTIC_TEST Iodine-124 Evuzamitide (I-124E)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2030-06-30 |
What is known before NCT07591038 opens enrollment
NCT07591038 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Iodine-124 Evuzamitide (I-124E) is the first listed.
NCT07591038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07591038 about?
NCT07591038 is a clinical study titled "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 ...
What is the current status of trial NCT07591038?
This trial is currently not yet recruiting. The enrollment target is 80 participants. The study started on 2026-08-01. Estimated completion is 2030-06-30.
What interventions are being tested in trial NCT07591038?
The interventions under investigation include: Iodine-124 Evuzamitide (I-124E) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07591038?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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