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NCT03735680 · FLOW

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A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer · Source last updated 2023-07-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
    id
    FG000
    title
    Part 1, Cohort A
  2. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg for safety evaluation and surgery and imaging at 3 ±2 hours post dose.
    id
    FG001
    title
    Part 1, Cohort B
  3. description
    Patients were administered a single dose of pegsitacianine (ONM-100) 2 mg/kg and evaluated whether alternate imaging schedules post dose (ie, other than 3 ±2 hours post dose) provided acceptable imaging results at doses ≤3 mg/kg.
    id
    FG002
    title
    Part 1, Cohort E
  4. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg. Surgery/imaging time hours to be determined (TBD).
    id
    FG003
    title
    Part 2, Group 2
  5. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg. Surgery/imaging time, hours 16-80.
    id
    FG004
    title
    Part 2, Group 3
  6. description
    Patients received a single dose of pegsitacianine (ONM-100) at 1 mg/kg administered at 24 ±8 hours prior to surgery.
    id
    FG005
    title
    Part 3
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Patient unable or unwilling to continue
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
    id
    FG000
    title
    Part 1, Cohort A
  2. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg for safety evaluation and surgery and imaging at 3 ±2 hours post dose.
    id
    FG001
    title
    Part 1, Cohort B
  3. description
    Patients were administered a single dose of pegsitacianine (ONM-100) 2 mg/kg and evaluated whether alternate imaging schedules post dose (ie, other than 3 ±2 hours post dose) provided acceptable imaging results at doses ≤3 mg/kg.
    id
    FG002
    title
    Part 1, Cohort E
  4. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg. Surgery/imaging time hours to be determined (TBD).
    id
    FG003
    title
    Part 2, Group 2
  5. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg. Surgery/imaging time, hours 16-80.
    id
    FG004
    title
    Part 2, Group 3
  6. description
    Patients received a single dose of pegsitacianine (ONM-100) at 1 mg/kg administered at 24 ±8 hours prior to surgery.
    id
    FG005
    title
    Part 3
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Patient unable or unwilling to continue
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        10
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice