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NCT02981368 · BASELINE

Baseline characteristics

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Source last updated 2021-08-09

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
      268
    2. group Id
      BG001
      value
      117
    3. group Id
      BG002
      value
      385
    units
    Participants
groups
  1. description
    Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
    id
    BG000
    title
    High Risk Prostate Cancer (Cohort A)
  2. description
    Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
    id
    BG001
    title
    Recurrent or Metastatic Prostate Cancer (Cohort B)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          84
          value
          65
        2. group Id
          BG001
          lower Limit
          45
          upper Limit
          86
          value
          68
        3. group Id
          BG002
          lower Limit
          45
          upper Limit
          86
          value
          66
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          385
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          334
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          29
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety population; total number of patients who received 18F-DCFPyL injection.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      268
    2. group Id
      BG001
      value
      117
    3. group Id
      BG002
      value
      385
    units
    Participants
groups
  1. description
    Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
    id
    BG000
    title
    High Risk Prostate Cancer (Cohort A)
  2. description
    Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
    id
    BG001
    title
    Recurrent or Metastatic Prostate Cancer (Cohort B)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          84
          value
          65
        2. group Id
          BG001
          lower Limit
          45
          upper Limit
          86
          value
          68
        3. group Id
          BG002
          lower Limit
          45
          upper Limit
          86
          value
          66
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          385
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          334
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          29
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Unknown or Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety population; total number of patients who received 18F-DCFPyL injection.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice