Evuzamitide in PET/CT to Measure Potential Therapeutic Response in ATTR

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05635045
Phase
PHASE2
Status
Completed

Conditions

  • Transthyretin Amyloidosis

Eligibility Criteria

Sex
ALL
Age
50 Years - 105 Years
Healthy Volunteers
Accepted

Interventions

  • I 124-Evuzamitide — DRUG
    Amyloid reactive protein used as imaging agent in whole body SPECT-CT imaging

Study Details

This was a single center, prospective cohort study that is evaluating the ability of 124I-evuzamitide PET scanning to detect potential therapeutic changes in subjects under treatment for ATTR after one year had elapsed since their original 124I-evuzamitide PET scan. Ten previously scanned subjects re-consented to undergo another 124I-evuzamitide PET scan. Demographic, clinical and phenotypic data were collected to characterize potential changes since their previous scans.

Key Dates

Start date
Jul 8, 2022
Status verified
Jul 2025
Primary completion
May 7, 2024
Completion
Jun 12, 2024

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Stabilizer Only
    Subjects treated with tafamidis selected to re-scan to determine the change over time in Evuzamitide uptake
  • Active Comparator: Silencer Only
    Subjects treated with vutrisiran selected to re-scan to determine the change over time in Evuzamitide uptake
  • Active Comparator: Stabilizer and Silencer (tafamidis + patisiran)
    Subjects treated with tafamidis and patisiran selected to re-scan to determine the change over time in Evuzamitide uptake
  • Active Comparator: Stabilizer and Silencer (vutrisiran + diflunisal)
    Subjects treated with vutrisiran and diflunisal selected to re-scan to determine the change over time in Evuzamitide uptake

Primary Outcome Measure

Median of Uptake of Evuzamitide as Measured by Volume of Interest in Milliliters [ Time Frame: Up to one month after imaging ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-

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By research site
Columbia University Irving Medical Center· New York, NY

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