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NCT03686215 · BASELINE

Baseline characteristics

Investigation of Novel Surgical Imaging for Tumor Excision · Source last updated 2023-08-24

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
      357
    2. group Id
      BG001
      value
      35
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      406
    units
    Participants
groups
  1. description
    The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
    id
    BG000
    title
    Device Intervention: LUM Imaging System Used During Surgery
  2. description
    The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm received the study drug, LUM015.
    id
    BG001
    title
    Standard of Care Arm
  3. description
    All the patients injected with LUM015 but withdrawn before randomization.
    id
    BG002
    title
    Withdrawn Before Randomization
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          211
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          173
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          195
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.6
          value
          62.4
        2. group Id
          BG001
          spread
          9.9
          value
          61.6
        3. group Id
          BG002
          spread
          11.6
          value
          61.6
        4. group Id
          BG003
          spread
          9.7
          value
          62.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          406
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          336
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          383
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          22
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          337
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          406
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.7
          value
          29.8
        2. group Id
          BG001
          spread
          5.9
          value
          31.0
        3. group Id
          BG002
          spread
          6.8
          value
          29.8
        4. group Id
          BG003
          spread
          6.6
          value
          29.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          339
        title
        Post
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          67
        title
        Pre/Peri
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopausal Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Almost Entirely Fatty
      2. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          220
        title
        Scattered Areas of Fibroglandular Density
      3. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          163
        title
        Heterogeneously Dense
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          13
        title
        Extremely Dense
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mammographic breast density
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          100
        title
        Palpable Mass
      2. measurements
        1. group Id
          BG000
          value
          272
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          306
        title
        Not palpable Mass
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Palpability
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          78
        title
        DCIS only
      2. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          284
        title
        IDC +/- DCIS
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          41
        title
        ILC +/- DCIS
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        IDC + ILC
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology From Biopsy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          335
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          378
        title
        ER (+)
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          25
        title
        ER (-)
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Not available
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Estrogen Receptor (ER) (+) Genetic Marker from Biopsy
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      357
    2. group Id
      BG001
      value
      35
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      406
    units
    Participants
groups
  1. description
    The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
    id
    BG000
    title
    Device Intervention: LUM Imaging System Used During Surgery
  2. description
    The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm received the study drug, LUM015.
    id
    BG001
    title
    Standard of Care Arm
  3. description
    All the patients injected with LUM015 but withdrawn before randomization.
    id
    BG002
    title
    Withdrawn Before Randomization
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          184
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          211
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          173
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          195
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.6
          value
          62.4
        2. group Id
          BG001
          spread
          9.9
          value
          61.6
        3. group Id
          BG002
          spread
          11.6
          value
          61.6
        4. group Id
          BG003
          spread
          9.7
          value
          62.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          406
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          336
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          383
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          22
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          26
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          297
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          337
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          357
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          406
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.7
          value
          29.8
        2. group Id
          BG001
          spread
          5.9
          value
          31.0
        3. group Id
          BG002
          spread
          6.8
          value
          29.8
        4. group Id
          BG003
          spread
          6.6
          value
          29.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          339
        title
        Post
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          67
        title
        Pre/Peri
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopausal Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Almost Entirely Fatty
      2. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          220
        title
        Scattered Areas of Fibroglandular Density
      3. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          163
        title
        Heterogeneously Dense
      4. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          13
        title
        Extremely Dense
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mammographic breast density
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          100
        title
        Palpable Mass
      2. measurements
        1. group Id
          BG000
          value
          272
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          306
        title
        Not palpable Mass
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Palpability
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          78
        title
        DCIS only
      2. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          284
        title
        IDC +/- DCIS
      3. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          41
        title
        ILC +/- DCIS
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        IDC + ILC
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Histology From Biopsy
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          335
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          378
        title
        ER (+)
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          25
        title
        ER (-)
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Not available
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Estrogen Receptor (ER) (+) Genetic Marker from Biopsy
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice