Trial Outcomes & Findings for Intraoperative Detection of Residual Cancer in Breast Cancer (NCT NCT03321929)
NCT ID: NCT03321929
Last Updated: 2023-05-01
Results Overview
Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System. This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove. It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
234 participants
Primary outcome timeframe
1 day
Results posted on
2023-05-01
Participant Flow
Per protocol, the enrolled population are those who were injected with LUM015.
Participant milestones
| Measure |
LUM Imaging System
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Overall Study
STARTED
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234
|
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Overall Study
COMPLETED
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230
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
LUM Imaging System
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Overall Study
Withdrawn prior to LUM Imaging Procedure completed
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4
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Baseline Characteristics
One patient did not have the height recorded in the system.
Baseline characteristics by cohort
| Measure |
LUM Imaging System
n=234 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
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|---|---|
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Age, Continuous
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61.7 years
STANDARD_DEVIATION 9.8 • n=234 Participants
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Sex: Female, Male
Female
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234 Participants
n=234 Participants
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Sex: Female, Male
Male
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0 Participants
n=234 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=234 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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220 Participants
n=234 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=234 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=234 Participants
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Race (NIH/OMB)
Asian
|
15 Participants
n=234 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=234 Participants
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Race (NIH/OMB)
Black or African American
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21 Participants
n=234 Participants
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Race (NIH/OMB)
White
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187 Participants
n=234 Participants
|
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Race (NIH/OMB)
More than one race
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2 Participants
n=234 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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9 Participants
n=234 Participants
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Region of Enrollment
United States
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234 participants
n=234 Participants
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Body Mass Index
|
29.0 Kg/m^2
STANDARD_DEVIATION 6.6 • n=233 Participants • One patient did not have the height recorded in the system.
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Menopausal Status
Post-menopausal
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187 Participants
n=234 Participants
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Menopausal Status
Pre/Peri-menopausal
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47 Participants
n=234 Participants
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Mammographic breast density
Almost entirely fatty
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12 Participants
n=234 Participants
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Mammographic breast density
Scattered areas of fibroglandular density
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119 Participants
n=234 Participants
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Mammographic breast density
Heterogeneously dense
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86 Participants
n=234 Participants
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Mammographic breast density
Extremely dense
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11 Participants
n=234 Participants
|
|
Mammographic breast density
Unknown
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6 Participants
n=234 Participants
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|
Palpability
Palpable mass
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63 Participants
n=234 Participants
|
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Palpability
Not palpable mass
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171 Participants
n=234 Participants
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PRIMARY outcome
Timeframe: 1 dayPopulation: modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed
Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System. This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove. It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.
Outcome measures
| Measure |
LUM Imaging System
n=230 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Collect Data to Refine and Verify the Tumor Detection Algorithm.
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11.3 Percentage
Interval 7.5 to 16.1
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SECONDARY outcome
Timeframe: Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit (Median 31 days after lumpectomy).Population: Subjects injected with LUM015 at a dose of 1mg/kg.
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Outcome measures
| Measure |
LUM Imaging System
n=234 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Number of Patients With Reported Adverse Events
Chromaturia Adverse Events · Severe, Related
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0 Participants
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Number of Patients With Reported Adverse Events
Chromaturia Adverse Events · Mild or Moderate, Not Related
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0 Participants
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Number of Patients With Reported Adverse Events
Chromaturia Adverse Events · Mild or Moderate, Related
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214 Participants
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Number of Patients With Reported Adverse Events
Chromaturia Adverse Events · Severe, Not Related
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0 Participants
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Number of Patients With Reported Adverse Events
Chromaturia Adverse Events · Life Threatening, Not Related
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0 Participants
|
|
Number of Patients With Reported Adverse Events
Chromaturia Adverse Events · Life Threatening, Related
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0 Participants
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Number of Patients With Reported Adverse Events
Non Chromaturia Adverse Events · Mild or Moderate, Not Related
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33 Participants
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Number of Patients With Reported Adverse Events
Non Chromaturia Adverse Events · Mild or Moderate, Related
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1 Participants
|
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Number of Patients With Reported Adverse Events
Non Chromaturia Adverse Events · Severe, Not Related
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0 Participants
|
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Number of Patients With Reported Adverse Events
Non Chromaturia Adverse Events · Severe, Related
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1 Participants
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Number of Patients With Reported Adverse Events
Non Chromaturia Adverse Events · Life Threatening, Not Related
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0 Participants
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Number of Patients With Reported Adverse Events
Non Chromaturia Adverse Events · Life Threatening, Related
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1 Participants
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SECONDARY outcome
Timeframe: 1 weekCollect data to verify the detection algorithm reported in previous studies by SOC margin status
Outcome measures
| Measure |
LUM Imaging System
n=230 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Tumor Removal Rate in the Whole mITT Population by SOC Margin Status
Percentage of subjects with positive SOC margins having tumor in at least one therapeutic shave.
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5.2 Percentage of All Subjects
Interval 2.7 to 8.9
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Tumor Removal Rate in the Whole mITT Population by SOC Margin Status
Percentage of subjects with negative SOC margins having tumor in at least one therapeutic shave.
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6.1 Percentage of All Subjects
Interval 3.4 to 10.0
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SECONDARY outcome
Timeframe: 1 WeekTumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had positive margins after SOC.
Outcome measures
| Measure |
LUM Imaging System
n=38 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins
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31.6 Percentage of Subjects
Interval 17.5 to 48.7
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SECONDARY outcome
Timeframe: 1 WeekTumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had negative margins after SOC.
Outcome measures
| Measure |
LUM Imaging System
n=192 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Tumor Removal Rate Within Subjects Having All Negative SOC Margins
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7.3 Percentage of Subjects
Interval 4.0 to 11.9
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SECONDARY outcome
Timeframe: 1 WeekSensitivity and specificity were measured at the tissue level for the Lumicell imaging signal for the sensitivity and specificity on the residual tumor in the cavity of corresponding orientations after standard of care (SOC) of Lumpectomy. Generalized Estimating Equation (GEE) has been applied using generalized linear model having binomial link function and compound symmetry working correlation structure within each subject.
Outcome measures
| Measure |
LUM Imaging System
n=230 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity
Sensitivity (GEE)
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69.3 Percentage
Interval 55.8 to 80.1
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Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity
Specificity (GEE)
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71.7 Percentage
Interval 68.5 to 74.7
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SECONDARY outcome
Timeframe: 1 WeekConversion was measured as the ratio of the subjects having all the positive margins after BCS SOC converted to negatives after Lumicell Imaging guided procedure. Detection was measured as the ratio of the subjects having all or at least one positive margin after BCS SOC detected by Lumicell Imaging System. BCS: Breast-conserving surgery; SOC: Standard of Care
Outcome measures
| Measure |
LUM Imaging System
n=38 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Detection and Conversion of Positive Margins in Subjects After BCS SOC
Percentage of Subjects Having SOC Positive Margins All Converted to Negative
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15.8 Percentage of All Subjects
Interval 6.0 to 31.3
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Detection and Conversion of Positive Margins in Subjects After BCS SOC
Percentage of Subjects Having SOC Positive Margins All Detected by Lumicell Device
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28.9 Percentage of All Subjects
Interval 15.4 to 45.9
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Detection and Conversion of Positive Margins in Subjects After BCS SOC
Percentage of Subjects Having At Least One SOC Positive Margin Detected by Lumicell Device
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42.1 Percentage of All Subjects
Interval 26.3 to 59.2
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SECONDARY outcome
Timeframe: 1 WeekPopulation: Total mITT population
The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well.
Outcome measures
| Measure |
LUM Imaging System
n=230 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Volume of Therapeutic Shaves Removed During Lumpectomy.
SOC total volume (cm3)
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65.4 Volume in CM^3
Interval 17.9 to 276.9
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Volume of Therapeutic Shaves Removed During Lumpectomy.
Lumpectomy volume (cm3)
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57.8 Volume in CM^3
Interval 11.5 to 252.7
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Volume of Therapeutic Shaves Removed During Lumpectomy.
SOC shave volume (cm3)
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6.0 Volume in CM^3
Interval 0.0 to 52.5
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Volume of Therapeutic Shaves Removed During Lumpectomy.
Therapeutic shave volume (cm3)
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4.0 Volume in CM^3
Interval 0.0 to 102.8
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Volume of Therapeutic Shaves Removed During Lumpectomy.
Total volume (cm3)
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77.7 Volume in CM^3
Interval 18.8 to 336.8
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SECONDARY outcome
Timeframe: 1 WeekPopulation: Total mITT population
The contribution of the volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured as percentage of the sum of the volumes of the therapeutic shaves out of the total volume removed during lumpectomy.
Outcome measures
| Measure |
LUM Imaging System
n=230 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.
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6.5 Percentage
Interval 0.0 to 55.9
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1 dayPopulation: Thirty-eight surgeons at 16 clinical sites were trained on the use of the LUM Imaging System.
Surgeons were trained on using the LUM Imaging System in preparation for participating in future clinical trials with the LUM Imaging System. Workflows were established at each institution to support the use of the LUM Imaging System and protocol adherence during lumpectomy procedures. Surgeons were not participants in the trial. Surgeons were the Investigators in the trial.
Outcome measures
| Measure |
LUM Imaging System
n=38 Participants
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Number of Surgeons Trained on the Use of the LUM Imaging System
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38 Participants
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Adverse Events
LUM Imaging System
Serious events: 1 serious events
Other events: 215 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LUM Imaging System
n=234 participants at risk
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Immune system disorders
Anaphylactic Reaction
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0.43%
1/234 • Number of events 1 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
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Other adverse events
| Measure |
LUM Imaging System
n=234 participants at risk
Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device
LUM Imaging System: LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
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|---|---|
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Renal and urinary disorders
Chromaturia
|
91.5%
214/234 • Number of events 214 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
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Injury, poisoning and procedural complications
Seroma
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2.1%
5/234 • Number of events 5 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
3/234 • Number of events 4 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
|
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Gastrointestinal disorders
Nausea
|
1.3%
3/234 • Number of events 3 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
3/234 • Number of events 3 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.85%
2/234 • Number of events 2 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
|
|
Vascular disorders
Haematoma
|
0.85%
2/234 • Number of events 2 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.85%
2/234 • Number of events 2 • All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.
Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60