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NCT05968846 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      19
    units
    Participants
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
    BG000
    title
    All Participants
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          63
          upper Limit
          76
          value
          72
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6
          upper Limit
          9
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Time Since SA Diagnosis
    unit Of Measure
    Years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.9
          value
          2.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since baseline imaging in AMY1001 study (years)
    unit Of Measure
    Years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        AL Kappa
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        AL Lambda
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        ATTR; Mutation type L58H
      4. measurements
        1. group Id
          BG000
          value
          5
        title
        ATTR; Mutation type T60A
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        ATTR; Mutation type V30M and V122I
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        ATTR; Mutation type Wild type
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Amyloid Type
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          9
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    % of AL patients; n=9
    title
    Amyloid therapy at time of imaging of AL
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Stabilizer only
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Silencer only
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Stabilizer and silencer
      denoms
      1. counts
        1. group Id
          BG000
          value
          10
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    % of ATTR patients; n=10, Abbreviations: AL = light chain-associated amyloidosis; ATTR = transthyretin-associated amyloidosis
    title
    Amyloid therapy at time of imaging of ATTR
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    units
    Participants
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
    BG000
    title
    All Participants
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          63
          upper Limit
          76
          value
          72
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6
          upper Limit
          9
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Time Since SA Diagnosis
    unit Of Measure
    Years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.9
          value
          2.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since baseline imaging in AMY1001 study (years)
    unit Of Measure
    Years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        title
        AL Kappa
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        AL Lambda
      3. measurements
        1. group Id
          BG000
          value
          3
        title
        ATTR; Mutation type L58H
      4. measurements
        1. group Id
          BG000
          value
          5
        title
        ATTR; Mutation type T60A
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        ATTR; Mutation type V30M and V122I
      6. measurements
        1. group Id
          BG000
          value
          1
        title
        ATTR; Mutation type Wild type
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Amyloid Type
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          9
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    % of AL patients; n=9
    title
    Amyloid therapy at time of imaging of AL
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Stabilizer only
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Silencer only
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Stabilizer and silencer
      denoms
      1. counts
        1. group Id
          BG000
          value
          10
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    % of ATTR patients; n=10, Abbreviations: AL = light chain-associated amyloidosis; ATTR = transthyretin-associated amyloidosis
    title
    Amyloid therapy at time of imaging of ATTR
    unit Of Measure
    Participants

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

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