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NCT05968846 · FLOW

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Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load · Source last updated 2026-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging 124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is an iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans. 124I-AT-01 has been evaluated previously in an open-label Phase 1/2 clinical trial, AMY1001, performed at the University of Tennessee Medical Center (IND# 132282; NCT T03678259). In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.
    id
    FG000
    title
    All Participants
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prior to assignment, potential participants were screened to verify their medical records, including confirming that participants must have been imaged with 124I-AT-01 as part of the AMY1001 study more than 12 months prior to the repeat imaging.
recruitment Details
Data of participants diagnosed with systemic AL or ATTR amyloidosis who were previously imaged with 124I-AT-01 as part of the AMY1001 study (NCT03678259) and in whom there was visually positive uptake of radiotracer in at least one abdominothoracic organ.
Complete source fields
groups
  1. description
    Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging 124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is an iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans. 124I-AT-01 has been evaluated previously in an open-label Phase 1/2 clinical trial, AMY1001, performed at the University of Tennessee Medical Center (IND# 132282; NCT T03678259). In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.
    id
    FG000
    title
    All Participants
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        19
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Prior to assignment, potential participants were screened to verify their medical records, including confirming that participants must have been imaged with 124I-AT-01 as part of the AMY1001 study more than 12 months prior to the repeat imaging.
recruitment Details
Data of participants diagnosed with systemic AL or ATTR amyloidosis who were previously imaged with 124I-AT-01 as part of the AMY1001 study (NCT03678259) and in whom there was visually positive uptake of radiotracer in at least one abdominothoracic organ.

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Preserved source evidence · Independent clinical review pending · Not medical advice