PET/CT Imaging in Carriers of TTR Mutations

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07591038
Status
Not Yet Recruiting

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Conditions

  • ATTR
  • ATTR Gene Mutation
  • Cardiomyopathy
  • Transthyretin Mediated Amyloidosis (ATTR)

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Iodine-124 Evuzamitide (I-124E) — DIAGNOSTIC_TEST
    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).

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Pathogenic TTR Allele Carriers without Heart Failure
  • Arm: Subjects with Symptomatic ATTR-CA
  • Arm: Non-carrier race-matched controls

Primary Outcome Measure

LV % Injected dose [ Time Frame: PET/CT Scan Visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75248
Jerah Sanchez
[email protected]
214-645-7303
Justin L Grodin, MD MPH (PRINCIPAL_INVESTIGATOR)
Vlad Zaha, MD PhD (SUB_INVESTIGATOR)
Lori Roth, PA-C (SUB_INVESTIGATOR)

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By research site
UT Southwestern Medical Center· Dallas, TX

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