Trial Outcomes & Findings for Feasibility Study of Intraoperative Imaging in Breast Cancer (NCT NCT02438358)
NCT ID: NCT02438358
Last Updated: 2023-01-05
Results Overview
tumor-to-normal tissue signal ratio as a function of dose of LUM015
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
1 day
Results posted on
2023-01-05
Participant Flow
Phase A enrolled 15 women undergoing lumpectomy for primary breast cancers assigned sequentially to one of the 3 different dose arms (no dose of LUM015, 0.5mg/kg of LUM015, and 1.0mg/kg of LUM015). Phase B patients enrolled until 10 patients had positive margins in their standard of care cavity shave or a maximum of 50 patients was reached, whichever happened first.
Participant milestones
| Measure |
Phase A: No Dose
5 participants were not injected with LUM015. All subjects will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase A: LUM015 0.5 mg/kg
5 participants received a single dose of LUM015 0.5 mg/kg administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase A: LUM015 1.0 mg/kg
5 participants received a single dose of LUM015 1.0 mg/kg administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase B: LUM015 1.0 mg/kg
45 participants received a single dose of LUM015 1.0 mg/kg administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
45
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all patient tumors were measured.
Baseline characteristics by cohort
| Measure |
Phase A: No Dose
n=5 Participants
5 participants were not administered with LLUM015 All participants will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase A: LUM015 0.5 mg/kg
n=5 Participants
5 participants were administered with LLUM015 at 0.5 mg/kg by intravenous injection between 2 to 6 hours prior to surgery.
All participants will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase A: LUM015 1.0 mg/kg
n=5 Participants
5 participants were administered with LLUM015 at 1.0 mg/kg by intravenous injection between 2 to 6 hours prior to surgery.
All participants will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase B: LUM015 1.0 mg/kg
n=45 Participants
45 participants were administered with a single dose of LUM015 at 1.0mg/kg by intravenous injection between 2 and 6 hours prior to surgery. Patients will then undergo lumpectomy followed by LUM imagining of the lumpectomy cavity. Comprehensive shaves will be performed followed by LUM015 imagining of the resulting cavity and resection of LUM-imagining-positive cavity tissue.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
65 years
n=5 Participants
|
59 years
n=5 Participants
|
60 years
n=45 Participants
|
60 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
45 Participants
n=45 Participants
|
60 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
39 Participants
n=45 Participants
|
54 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=45 Participants
|
6 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=45 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=45 Participants
|
53 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=5 Participants
|
5 participants
n=5 Participants
|
45 participants
n=45 Participants
|
60 participants
n=60 Participants
|
|
Cancer Histologic Type (from surgical excision)
Invasive Ductal Carcinoma with or without Ductal Carcinoma In Situ
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=45 Participants
|
36 Participants
n=60 Participants
|
|
Cancer Histologic Type (from surgical excision)
Invasive Lobular Carcinoma with or without Ductal Carcinoma In Situ
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=45 Participants
|
7 Participants
n=60 Participants
|
|
Cancer Histologic Type (from surgical excision)
Invasive Ductal Carcinoma and Invasive Lobular Carcinoma with or without Ductal Carcinoma In Situ
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=45 Participants
|
2 Participants
n=60 Participants
|
|
Cancer Histologic Type (from surgical excision)
Pure Ductal Carcinoma In Situ
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=45 Participants
|
13 Participants
n=60 Participants
|
|
Cancer Histologic Type (from surgical excision)
No Tumor Found
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=60 Participants
|
|
Invasive Tumor Size in Largest Dimension
|
1 cm
n=3 Participants • Not all patient tumors were measured.
|
1.85 cm
n=4 Participants • Not all patient tumors were measured.
|
1.6 cm
n=4 Participants • Not all patient tumors were measured.
|
1.2 cm
n=37 Participants • Not all patient tumors were measured.
|
1.2 cm
n=48 Participants • Not all patient tumors were measured.
|
|
Patients with Node Positive Disease
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
1 Participants
n=5 Participants • Not all patients were diagnosed.
|
6 Participants
n=45 Participants • Not all patients were diagnosed.
|
7 Participants
n=60 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Her-2 · Positives
|
1 Participants
n=4 Participants • Not all patients were diagnosed.
|
2 Participants
n=4 Participants • Not all patients were diagnosed.
|
1 Participants
n=4 Participants • Not all patients were diagnosed.
|
8 Participants
n=30 Participants • Not all patients were diagnosed.
|
12 Participants
n=42 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Her-2 · Negatives
|
3 Participants
n=4 Participants • Not all patients were diagnosed.
|
2 Participants
n=4 Participants • Not all patients were diagnosed.
|
3 Participants
n=4 Participants • Not all patients were diagnosed.
|
22 Participants
n=30 Participants • Not all patients were diagnosed.
|
30 Participants
n=42 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Her-2 · Neither triple negative nor triple positive
|
NA Participants
n=4 Participants • Not all patients were diagnosed.
|
NA Participants
n=4 Participants • Not all patients were diagnosed.
|
NA Participants
n=4 Participants • Not all patients were diagnosed.
|
NA Participants
n=30 Participants • Not all patients were diagnosed.
|
NA Participants
n=42 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Estrogen Receptor (ER) · Positives
|
5 Participants
n=5 Participants • Not all patients were diagnosed.
|
5 Participants
n=5 Participants • Not all patients were diagnosed.
|
4 Participants
n=5 Participants • Not all patients were diagnosed.
|
19 Participants
n=24 Participants • Not all patients were diagnosed.
|
33 Participants
n=39 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Estrogen Receptor (ER) · Negatives
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
1 Participants
n=5 Participants • Not all patients were diagnosed.
|
5 Participants
n=24 Participants • Not all patients were diagnosed.
|
6 Participants
n=39 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Estrogen Receptor (ER) · Neither triple negative nor triple positive
|
NA Participants
n=5 Participants • Not all patients were diagnosed.
|
NA Participants
n=5 Participants • Not all patients were diagnosed.
|
NA Participants
n=5 Participants • Not all patients were diagnosed.
|
NA Participants
n=24 Participants • Not all patients were diagnosed.
|
NA Participants
n=39 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Progesterone Receptor (PR) · Positives
|
5 Participants
n=5 Participants • Not all patients were diagnosed.
|
5 Participants
n=5 Participants • Not all patients were diagnosed.
|
4 Participants
n=5 Participants • Not all patients were diagnosed.
|
17 Participants
n=24 Participants • Not all patients were diagnosed.
|
31 Participants
n=39 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Progesterone Receptor (PR) · Negatives
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
1 Participants
n=5 Participants • Not all patients were diagnosed.
|
7 Participants
n=24 Participants • Not all patients were diagnosed.
|
8 Participants
n=39 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
Progesterone Receptor (PR) · Neither triple negative nor triple positive
|
NA Participants
n=5 Participants • Not all patients were diagnosed.
|
NA Participants
n=5 Participants • Not all patients were diagnosed.
|
NA Participants
n=5 Participants • Not all patients were diagnosed.
|
NA Participants
n=24 Participants • Not all patients were diagnosed.
|
NA Participants
n=39 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
All Triple Her-2, ER, PR · Positives
|
1 Participants
n=5 Participants • Not all patients were diagnosed.
|
2 Participants
n=5 Participants • Not all patients were diagnosed.
|
1 Participants
n=5 Participants • Not all patients were diagnosed.
|
0 Participants
n=23 Participants • Not all patients were diagnosed.
|
4 Participants
n=38 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
All Triple Her-2, ER, PR · Negatives
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
0 Participants
n=5 Participants • Not all patients were diagnosed.
|
1 Participants
n=5 Participants • Not all patients were diagnosed.
|
4 Participants
n=23 Participants • Not all patients were diagnosed.
|
5 Participants
n=38 Participants • Not all patients were diagnosed.
|
|
Tumor Receptors
All Triple Her-2, ER, PR · Neither triple negative nor triple positive
|
4 Participants
n=5 Participants • Not all patients were diagnosed.
|
3 Participants
n=5 Participants • Not all patients were diagnosed.
|
3 Participants
n=5 Participants • Not all patients were diagnosed.
|
19 Participants
n=23 Participants • Not all patients were diagnosed.
|
29 Participants
n=38 Participants • Not all patients were diagnosed.
|
|
Menopausal Status
Post-menopause
|
5 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=45 Participants
|
27 Participants
n=60 Participants
|
|
Menopausal Status
Pre/Peri-menopause
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
31 Participants
n=45 Participants
|
33 Participants
n=60 Participants
|
|
Mammographic Breast Density
Almost Entirely Fatty
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=45 Participants
|
3 Participants
n=60 Participants
|
|
Mammographic Breast Density
Scattered Areas of Fibroglandular/Heterogeneously Dense
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
18 Participants
n=45 Participants
|
21 Participants
n=60 Participants
|
|
Mammographic Breast Density
Heterogeneously Dense
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=45 Participants
|
31 Participants
n=60 Participants
|
|
Mammographic Breast Density
Extremely Dense
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=45 Participants
|
2 Participants
n=60 Participants
|
|
Mammographic Breast Density
Mixed Scattered Fibroglandular/Heterogeneously Dense
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=45 Participants
|
3 Participants
n=60 Participants
|
|
Physical Examination Findings
Palpable Mass
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=45 Participants
|
16 Participants
n=60 Participants
|
|
Physical Examination Findings
No Palpable Mass
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
32 Participants
n=45 Participants
|
44 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 5 patients not injected with LUM015, 5 patients injected with LUM015 at 0.5 mg/kg, and 5 patients injected with LUM015 at 1.0 mg/kg.
tumor-to-normal tissue signal ratio as a function of dose of LUM015
Outcome measures
| Measure |
Phase A No LUM015
n=5 Participants
(Phase A only) 5 patients not injected with LUM015
|
Phase A 0.5 mg/kg
n=5 Participants
(Phase A only) 5 patients injected with 0.5 mg/kg of LUM015
|
Phase A 1.0 mg/kg
n=5 Participants
(Phase A only) 5 patients injected with 1.0 mg/kg of LUM015
|
Phase B: LUM015 1. mg/kg
45 participants were administered with a single dose of LUM015 at 1.0mg/kg by intravenous injection between 2 and 6 hours prior to surgery. Patients will then undergo lumpectomy followed by LUM imagining of the lumpectomy cavity. Comprehensive shaves will be performed followed by LUM015 imagining of the resulting cavity and resection of LUM-imagining-positive cavity tissue.
|
|---|---|---|---|---|
|
(Phase A Only) Selection of Dose of LUM015 to be Used in Future Breast Trials
|
2.1 Ratio
Standard Deviation 0.7
|
4.7 Ratio
Standard Deviation 2.0
|
4.2 Ratio
Standard Deviation 2.1
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Intent to treat population.
Data from the participants in Phase A was used to develop an initial tumor detection algorithm that was then tested in Phase B. Thus, this endpoint is only applicable to the participants enrolled in the Phase B portion of the study. This endpoint measures the ability of the system to detect cancer as measured by sensitivity and specificity as defined below: Sensitivity = \[number of true positives/(number of true positives + number of false negatives)\] x 100% Specificity = \[number of true negatives/(number of true negatives + number of false positives)\] x 100% True positives = positive signal from imaging system and cancer found in tissue by pathology False positives = positive signal from imaging system and no cancer found in tissue by pathology True negatives = negative signal from imaging system and no cancer found in tissue by pathology False negatives = negative signal from imaging system and cancer found in tissue by pathology
Outcome measures
| Measure |
Phase A No LUM015
n=45 Participants
(Phase A only) 5 patients not injected with LUM015
|
Phase A 0.5 mg/kg
(Phase A only) 5 patients injected with 0.5 mg/kg of LUM015
|
Phase A 1.0 mg/kg
(Phase A only) 5 patients injected with 1.0 mg/kg of LUM015
|
Phase B: LUM015 1. mg/kg
45 participants were administered with a single dose of LUM015 at 1.0mg/kg by intravenous injection between 2 and 6 hours prior to surgery. Patients will then undergo lumpectomy followed by LUM imagining of the lumpectomy cavity. Comprehensive shaves will be performed followed by LUM015 imagining of the resulting cavity and resection of LUM-imagining-positive cavity tissue.
|
|---|---|---|---|---|
|
(Phase B Only)Sensitivity and Specificity of the Lumicell Imaging System for Detecting Cancer
Sensitivity
|
84 percentage of measurements
Interval 79.5 to 88.5
|
—
|
—
|
—
|
|
(Phase B Only)Sensitivity and Specificity of the Lumicell Imaging System for Detecting Cancer
Specificity
|
73 percentage of measurements
Interval 68.5 to 77.5
|
—
|
—
|
—
|
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: Intent to treat population.
Serious Adverse Events: Include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Non-Serious Adverse Events: Adverse events that are not Serious Adverse Events.
Outcome measures
| Measure |
Phase A No LUM015
n=5 Participants
(Phase A only) 5 patients not injected with LUM015
|
Phase A 0.5 mg/kg
n=5 Participants
(Phase A only) 5 patients injected with 0.5 mg/kg of LUM015
|
Phase A 1.0 mg/kg
n=5 Participants
(Phase A only) 5 patients injected with 1.0 mg/kg of LUM015
|
Phase B: LUM015 1. mg/kg
n=45 Participants
45 participants were administered with a single dose of LUM015 at 1.0mg/kg by intravenous injection between 2 and 6 hours prior to surgery. Patients will then undergo lumpectomy followed by LUM imagining of the lumpectomy cavity. Comprehensive shaves will be performed followed by LUM015 imagining of the resulting cavity and resection of LUM-imagining-positive cavity tissue.
|
|---|---|---|---|---|
|
Number of Patients With Adverse Events as a Measure of Safety of the LUM Imaging System in Breast Cancer Subjects.
Serious Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events as a Measure of Safety of the LUM Imaging System in Breast Cancer Subjects.
Non-Serious Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
Adverse Events
Phase A: No Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase A: LUM015 0.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase A: LUM015 1.0 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase B: LUM015 1.0 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase A: No Dose
n=5 participants at risk
5 participants were not administered with LUM015. All participants will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase A: LUM015 0.5 mg/kg
n=5 participants at risk
5 participants were administered with a single dose of LUM015 at 0.5 mg/kg by intravenous injection between 2 and 6 hours prior to surgery. All participants will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase A: LUM015 1.0 mg/kg
n=5 participants at risk
5 participants were administered with a single dose of LUM015 at 1.0 mg/kg by intravenous injection between 2 and 6 hours prior to surgery. All participants will have intraoperative imaging using the LUM 2.6 Imaging Device.
|
Phase B: LUM015 1.0 mg/kg
n=45 participants at risk
45 participants were administered with a single dose of LUM015 at 1.0 mg/kg by intravenous injection between 2 and 6 hours prior to surgery. Participants will then undergo lumpectomy followed by LUM imagining of the lumpectomy cavity. Comprehensive shaves will be performed followed by LUM015 imagining of the resulting cavity and resection of LUM-imagining-positive cavity tissue.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
2.2%
1/45 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
|
Injury, poisoning and procedural complications
Post Procedural Hematoma
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
2.2%
1/45 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
2.2%
1/45 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
|
General disorders
Extravasation
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
2.2%
1/45 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
|
Injury, poisoning and procedural complications
Suture Related Complication
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
0.00%
0/5 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
2.2%
1/45 • Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place