Skip to content
TriangleGet started
← Full study record

NCT05968846 · OUTCOME

To Measure Visual Changes and Quantitative Changes in Organ-specific Uptake of 124I-AT-01

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline PET/CT imaging from AMY1001 (NCT03678259) and repeat PET/CT imaging on Day 2 of the current study

What was measured

The goal of this research study is to determine whether changes in organ-specific uptake of 124I- AT-01 can be measured by PET/CT imaging and further, whether these values correlate with changes in a subject's disease status and thereby enable monitoring of disease response over time in terms of organ-specific amyloid load. The specific aim of this study is to measure visual and quantitative changes in organ-specific uptake of 124I-AT-01 from baseline, in patients with systemic amyloidosis, using PET/CT imaging

Analysis population: Summary of change in visual radiotracer uptake from baseline PET/CT imaging

Groups in this outcome

All Participants

Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Participants19

Reported measurements

Heart

No change in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants16Not reportedNot reportedNot reportedNot reported

With visual increase

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants1Not reportedNot reportedNot reportedNot reported

Decrease in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants2Not reportedNot reportedNot reportedNot reported
Liver

No change in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants12Not reportedNot reportedNot reportedNot reported

With visual increase

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants1Not reportedNot reportedNot reportedNot reported

Decrease in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants6Not reportedNot reportedNot reportedNot reported
Spleen

No change in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants14Not reportedNot reportedNot reportedNot reported

With visual increase

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0Not reportedNot reportedNot reportedNot reported

Decrease in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants5Not reportedNot reportedNot reportedNot reported
Kidney

No change in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants14Not reportedNot reportedNot reportedNot reported

With visual increase

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants4Not reportedNot reportedNot reportedNot reported

Decrease in visual uptake

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      title
      No change in visual uptake
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      With visual increase
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      Decrease in visual uptake
    title
    Heart
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      title
      No change in visual uptake
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      With visual increase
    3. measurements
      1. group Id
        OG000
        value
        6
      title
      Decrease in visual uptake
    title
    Liver
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      title
      No change in visual uptake
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      With visual increase
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      Decrease in visual uptake
    title
    Spleen
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      title
      No change in visual uptake
    2. measurements
      1. group Id
        OG000
        value
        4
      title
      With visual increase
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Decrease in visual uptake
    title
    Kidney
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
The goal of this research study is to determine whether changes in organ-specific uptake of 124I- AT-01 can be measured by PET/CT imaging and further, whether these values correlate with changes in a subject's disease status and thereby enable monitoring of disease response over time in terms of organ-specific amyloid load. The specific aim of this study is to measure visual and quantitative changes in organ-specific uptake of 124I-AT-01 from baseline, in patients with systemic amyloidosis, using PET/CT imaging
groups
  1. description
    Experimental: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging 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
    OG000
    title
    All Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Summary of change in visual radiotracer uptake from baseline PET/CT imaging
reporting Status
POSTED
time Frame
Baseline PET/CT imaging from AMY1001 (NCT03678259) and repeat PET/CT imaging on Day 2 of the current study
title
To Measure Visual Changes and Quantitative Changes in Organ-specific Uptake of 124I-AT-01
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

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