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NCT03735680 · OUTCOME

Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]

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.

Measure
MEAN
Unit
ratio
Interval / dispersion
Standard Deviation
Time frame
1 day

What was measured

Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma \[NSCLC\]). Part 3: Assess the safety and efficacy (sensitivity and positive predictive value \[PPV\] of ONM-100 for intraoperative imaging during HNSCC surgery.

Groups in this outcome

Part 1, Cohort A

All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.

Part 1, Cohort B

All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.

Part 1, Cohort E

All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.

Part 2, Group 2

All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.

Part 2, Group 3

All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.

Part 3

All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1, Cohort A1
Part 1, Cohort B3
Part 1, Cohort E3
Part 2, Group 24
Part 2, Group 36
Part 311

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1, Cohort A1.0980Not reportedNot reportedNot reported
Part 1, Cohort B4.0222.8139Not reportedNot reportedNot reported
Part 1, Cohort E2.2801.6393Not reportedNot reportedNot reported
Part 2, Group 24.1101.2527Not reportedNot reportedNot reported
Part 2, Group 33.0071.3822Not reportedNot reportedNot reported
Part 32.6082.5936Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        1.098
      2. group Id
        OG001
        spread
        2.8139
        value
        4.022
      3. group Id
        OG002
        spread
        1.6393
        value
        2.280
      4. group Id
        OG003
        spread
        1.2527
        value
        4.110
      5. group Id
        OG004
        spread
        1.3822
        value
        3.007
      6. group Id
        OG005
        spread
        2.5936
        value
        2.608
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      11
    units
    Participants
description
Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma \[NSCLC\]). Part 3: Assess the safety and efficacy (sensitivity and positive predictive value \[PPV\] of ONM-100 for intraoperative imaging during HNSCC surgery.
dispersion Type
Standard Deviation
groups
  1. description
    All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.
    id
    OG000
    title
    Part 1, Cohort A
  2. description
    All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.
    id
    OG001
    title
    Part 1, Cohort B
  3. description
    All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.
    id
    OG002
    title
    Part 1, Cohort E
  4. description
    All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.
    id
    OG003
    title
    Part 2, Group 2
  5. description
    All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
    id
    OG004
    title
    Part 2, Group 3
  6. description
    All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.
    id
    OG005
    title
    Part 3
param Type
MEAN
reporting Status
POSTED
time Frame
1 day
title
Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]
type
PRIMARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice