Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03686215 · OUTCOME

Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity

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.

Measure
NUMBER
Unit
percentage of negative margins w/o ca
Interval / dispersion
95% Confidence Interval
Time frame
Day 1, during surgery

What was measured

Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity was measured as percentage of the negative margins without cancer, that were tested negative by LUM Imaging System. The estimate of the instrument diagnostic specificity used Generalized Estimating Equations (GEE) approach with random effects from intraclass correlation within subjects.

Analysis population: modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

Groups in this outcome

Device Intervention: LUM Imaging System Used During Surgery

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.

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

Analysis denominator · Participants

GroupSource count
Device Intervention: LUM Imaging System Used During Surgery357

Analysis denominator · Negative margins without cancer

GroupSource count
Device Intervention: LUM Imaging System Used During Surgery2277

Reported measurements

Source class 1
Values in percentage of negative margins w/o ca · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Device Intervention: LUM Imaging System Used During Surgery86.5Not reported84.588.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.5
        upper Limit
        88.3
        value
        86.5
denom Units Selected
Negative margins without cancer
denoms
  1. counts
    1. group Id
      OG000
      value
      357
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      2277
    units
    Negative margins without cancer
description
Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity was measured as percentage of the negative margins without cancer, that were tested negative by LUM Imaging System. The estimate of the instrument diagnostic specificity used Generalized Estimating Equations (GEE) approach with random effects from intraclass correlation within subjects.
dispersion Type
95% Confidence Interval
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
    OG000
    title
    Device Intervention: LUM Imaging System Used During Surgery
param Type
NUMBER
population Description
modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed
reporting Status
POSTED
time Frame
Day 1, during surgery
title
Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity
type
PRIMARY
type Units Analyzed
Negative margins without cancer
unit Of Measure
percentage of negative margins w/o ca

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

Preserved source evidence · Not medical advice