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NCT04241315 · OUTCOME

Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting · Source last updated 2023-03-23

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

Measure
NUMBER
Unit
proportion of lesions
Interval / dispersion
95% Confidence Interval
Time frame
1 day

What was measured

Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.

Analysis population: Total number of Subjects with Evaluated Tissues

Groups in this outcome

Fully Analysis Set (FAS)

The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging

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

Analysis denominator · Participants

GroupSource count
Fully Analysis Set (FAS)89

Analysis denominator · Lesions

GroupSource count
Fully Analysis Set (FAS)104

Reported measurements

Source class 1
Values in proportion of lesions · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fully Analysis Set (FAS).765Not reported.667.842Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .667
        upper Limit
        .842
        value
        .765
denom Units Selected
Lesions
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      104
    units
    Lesions
description
Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.
dispersion Type
95% Confidence Interval
groups
  1. description
    The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
    id
    OG000
    title
    Fully Analysis Set (FAS)
param Type
NUMBER
population Description
Total number of Subjects with Evaluated Tissues
reporting Status
POSTED
time Frame
1 day
title
Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects
type
SECONDARY
type Units Analyzed
Lesions
unit Of Measure
proportion of lesions

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

Preserved source evidence · Not medical advice