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NCT05968846 · OUTCOME

Measures 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, ATTR and all patients, we will correlate visual and quantitative changes in 124I- AT-01 uptake, from baseline, in the heart, liver and kidney with echocardiographic parameters (including left ventricular wall thickness (cm), intraventricular wall thickness (cm), and global logitudinal strain (%)) and serum biomarker levels (including NTproBNP, eGFR, creatinine, AST and ALT) assessed prior to imaging and from data recorded in the patients' medical record.

Analysis population: For serum biomarker (NT-proBNP), correlations are reported for both the absolute repeat values and the change from baseline. Because echocardiographic data was not available from the baseline imaging session, the correlation for echocardiographic parameters was performed using absolute values at repeat 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

Cardiac SUVR change (%) vs NTproBNP change (%)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.57Not reportedNot reportedNot reportedNot reported
Scaled cardiac SUVR change (%) vs NTproBNP change (%)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.62Not reportedNot reportedNot reportedNot reported
Cardiac SUVR change vs NTproBNP change (pg/mL)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.43Not reportedNot reportedNot reportedNot reported
correlation with cardiac SUVR - Left Ventricular (LV) wall thickness (cm) (Repat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.76Not reportedNot reportedNot reportedNot reported
Correlation with cardiac SUVR - interventricular septum thickness (cm) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.68Not reportedNot reportedNot reportedNot reported
Correlation with cardiac SUVR - global longitudinal strain (GLS)(%) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.54Not reportedNot reportedNot reportedNot reported
Correlation with cardiac SUVR - NTproBNP (pg/mL) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.65Not reportedNot reportedNot reportedNot reported
Correlation with renal SUVR - estimated glomerular filtration rate (eGFR) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants-0.43Not reportedNot reportedNot reportedNot reported
Correlation with renal SUVR - Creatinine (Repat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.47Not reportedNot reportedNot reportedNot reported
Correlation with renal SUVR - blood urea nitrogen (BUN) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.25Not reportedNot reportedNot reportedNot reported
Correlation with renal SUVR - Urinary albumin/cre ratio (mg/g cre) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.00Not reportedNot reportedNot reportedNot reported
Correlation with hepatic SUVR - Aspartate Aminotransferase (AST) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.06Not reportedNot reportedNot reportedNot reported
Correlation with hepatic SUVR - Alanine transaminase (ALT) (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.18Not reportedNot reportedNot reportedNot reported
Correlation with hepatic SUVR - Alkaline phosphatase (Repeat Imaging)
Values in spearman correlation coefficient · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Participants0.29Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.57
    title
    Cardiac SUVR change (%) vs NTproBNP change (%)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.62
    title
    Scaled cardiac SUVR change (%) vs NTproBNP change (%)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.43
    title
    Cardiac SUVR change vs NTproBNP change (pg/mL)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.76
    title
    correlation with cardiac SUVR - Left Ventricular (LV) wall thickness (cm) (Repat Imaging)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.68
    title
    Correlation with cardiac SUVR - interventricular septum thickness (cm) (Repeat Imaging)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.54
    title
    Correlation with cardiac SUVR - global longitudinal strain (GLS)(%) (Repeat Imaging)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.65
    title
    Correlation with cardiac SUVR - NTproBNP (pg/mL) (Repeat Imaging)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        -0.43
    title
    Correlation with renal SUVR - estimated glomerular filtration rate (eGFR) (Repeat Imaging)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0.47
    title
    Correlation with renal SUVR - Creatinine (Repat Imaging)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0.25
    title
    Correlation with renal SUVR - blood urea nitrogen (BUN) (Repeat Imaging)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0.00
    title
    Correlation with renal SUVR - Urinary albumin/cre ratio (mg/g cre) (Repeat Imaging)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0.06
    title
    Correlation with hepatic SUVR - Aspartate Aminotransferase (AST) (Repeat Imaging)
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
For AL, ATTR and all patients, we will correlate visual and quantitative changes in 124I- AT-01 uptake, from baseline, in the heart, liver and kidney with echocardiographic parameters (including left ventricular wall thickness (cm), intraventricular wall thickness (cm), and global logitudinal strain (%)) and serum biomarker levels (including NTproBNP, eGFR, creatinine, AST and ALT) assessed prior to imaging and from data recorded in the patients' medical record.
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
For serum biomarker (NT-proBNP), correlations are reported for both the absolute repeat values and the change from baseline. Because echocardiographic data was not available from the baseline imaging session, the correlation for echocardiographic parameters was performed using absolute values at repeat imaging.
reporting Status
POSTED
time Frame
Baseline (assessed during previous study NCT03678259) and Repeat Assessment (Day 1 to Day 2 of current study)
title
Measures 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