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NCT05968846 · OUTCOME

Measure of Interest

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
NUMBER
Unit
spearman correlation coefficient
Interval / dispersion
Not reported
Time frame
Baseline (assessed during previous study NCT03678259) and Repeat Assessment (Day 1 to Day 2 of current study)

What was measured

For AL patients, correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in serum free light chains over the period between imaging studies, when available in the medical record. Baseline assessments reflect the values assessed during the previous study (NCT03678259). Repeat assessments reflect the values assessed during this current study. The 'change in' values are calculated as the repeat value from this current study minus the baseline value from the previous study (NCT03678259).

Analysis population: Of the 19 total enrolled participants, this analysis is limited to the 9 patients with AL amyloidosis because evaluating the difference between involved and uninvolved serum free light chains (dFLC) is clinically relevant only to that cohort. Correlation (Spearman) analyses were performed to assess the relationship between the change in radiotracer uptake (SUVR) and changes in dFLC and the free κ/λ ratio.

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 Participants9

Reported measurements

Heart SUVRmean change (%) - dFLC change
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.262Not reportedNot reportedNot reportedNot reported
Heart SUVRmean change (%) - κ/λ ratio change
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.619Not reportedNot reportedNot reportedNot reported
Change in SUVRmean absolute - dFLC change
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.252Not reportedNot reportedNot reportedNot reported
Change in SUVRmean absolute - κ/λ ratio change
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.515Not reportedNot reportedNot reportedNot reported
Heart SUVRmean change (%) - Baseline dFLC
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.405Not reportedNot reportedNot reportedNot reported
Heart SUVRmean change (%) - Repeat dFLC
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.929Not reportedNot reportedNot reportedNot reported
Change in SUVRmean absolute - Baseline dFLC
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.491Not reportedNot reportedNot reportedNot reported
Change in SUVRmean absolute - Repeat dFLC
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.970Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.262
    title
    Heart SUVRmean change (%) - dFLC change
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.619
    title
    Heart SUVRmean change (%) - κ/λ ratio change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.252
    title
    Change in SUVRmean absolute - dFLC change
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.515
    title
    Change in SUVRmean absolute - κ/λ ratio change
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.405
    title
    Heart SUVRmean change (%) - Baseline dFLC
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.929
    title
    Heart SUVRmean change (%) - Repeat dFLC
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.491
    title
    Change in SUVRmean absolute - Baseline dFLC
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.970
    title
    Change in SUVRmean absolute - Repeat dFLC
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
For AL patients, correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in serum free light chains over the period between imaging studies, when available in the medical record. Baseline assessments reflect the values assessed during the previous study (NCT03678259). Repeat assessments reflect the values assessed during this current study. The 'change in' values are calculated as the repeat value from this current study minus the baseline value from the previous study (NCT03678259).
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
NUMBER
population Description
Of the 19 total enrolled participants, this analysis is limited to the 9 patients with AL amyloidosis because evaluating the difference between involved and uninvolved serum free light chains (dFLC) is clinically relevant only to that cohort. Correlation (Spearman) analyses were performed to assess the relationship between the change in radiotracer uptake (SUVR) and changes in dFLC and the free κ/λ ratio.
reporting Status
POSTED
time Frame
Baseline (assessed during previous study NCT03678259) and Repeat Assessment (Day 1 to Day 2 of current study)
title
Measure of Interest
type
OTHER_PRE_SPECIFIED
unit Of Measure
spearman correlation coefficient

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

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