Trial Outcomes & Findings for Real-time Intraoperative Breast Cancer Visualization for Margin Assessment (NCT NCT02807597)

Results Overview

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Time of injection to 3 hours post-injection

Results posted on

2025-08-17

Participant Flow

9 subjects started and completed phase 1a period (14-15 months). Study was terminated and did not proceed to the next phases planned in the next period 2.

Participant milestones

Participant milestones
Measure	Phase I Dose Level 1: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (0.05 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Level 2: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (0.075 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Level 3: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (0.1 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care
Phase 1 Period (14-15 Months) STARTED	3	3	3
Phase 1 Period (14-15 Months) COMPLETED	3	3	3
Phase 1 Period (14-15 Months) NOT COMPLETED	0	0	0
Phase 2 Period (2 Months) STARTED	0	0	0
Phase 2 Period (2 Months) COMPLETED	0	0	0
Phase 2 Period (2 Months) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LS301 (0.05 mg/Kg) n=3 Participants Subjects who were enrolled for LS301 dose (0.05 mg/Kg) in Phase 1a. Phase 1b and rest of the phases did not start.	LS301 (0.075 mg/Kg) n=3 Participants Subjects who were enrolled for LS301 dose (0.075 mg/Kg) in Phase 1a. Phase 1b and rest of the phases did not start.	LS301 (0.1 mg/Kg) n=3 Participants Subjects who were enrolled for LS301 dose (0.1 mg/Kg) in Phase 1a. Phase 1b and rest of the phases did not start.	Total n=9 Participants Total of all reporting groups
Age, Customized 54 to 74 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Body mass index	27.17 kg/m2 STANDARD_DEVIATION 0.49 • n=5 Participants	30.9 kg/m2 STANDARD_DEVIATION 6.14 • n=7 Participants	27.17 kg/m2 STANDARD_DEVIATION 3.38 • n=5 Participants	28.41 kg/m2 STANDARD_DEVIATION 3.98 • n=4 Participants

PRIMARY outcome

Timeframe: Time of injection to 3 hours post-injection

Population: Since this outcome measure is specific to phase I, no data was collected for Phase I Dose Expansion Arm and Phase II Arm.

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1: LS301 n=3 Participants * Patient will undergo surgery 4-24 hours after administration of LS301 (0.05 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Level 2: LS301 n=3 Participants * Patient will undergo surgery 4-24 hours after administration of LS301 (0.075 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Level 3: LS301 n=3 Participants * Patient will undergo surgery 4-24 hours after administration of LS301 (0.1 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Expansion: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (dose to be determined in Phase I dose escalation portion) * 9 patients will be enrolled (6 invasive ductal carcinoma and 3 DCIS) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase II: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (dose to be determined in Phase I portion) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care
Number of Participants With Related Adverse Events of LS301 in Breast (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 14-15 months

Population: This outcome is specific to Phase 1 and since due to study termination, it never proceeded to the next phases after phase 1a was completed.

* Optimal dose will be the dose at which fewer than 2 dose-limiting toxicities (DLTs) are observed and optimal image quality is observed. It need not be the maximum tolerated dose (MTD) if optimal image quality is observed at a lower dose than the MTD. * DLT is defined as any grade 2 or above toxicity that occurs during the hour after injection that is considered possibly, probably, or definitely related to LS301 * Toxicities will be graded using the NCI Common Terminology Criteria for Adverse Events version 5.0

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1: LS301 n=3 Participants * Patient will undergo surgery 4-24 hours after administration of LS301 (0.05 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Level 2: LS301 n=3 Participants * Patient will undergo surgery 4-24 hours after administration of LS301 (0.075 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Level 3: LS301 n=3 Participants * Patient will undergo surgery 4-24 hours after administration of LS301 (0.1 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase I Dose Expansion: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (dose to be determined in Phase I dose escalation portion) * 9 patients will be enrolled (6 invasive ductal carcinoma and 3 DCIS) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care	Phase II: LS301 * Patient will undergo surgery 4-24 hours after administration of LS301 (dose to be determined in Phase I portion) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data. LS301: -LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. Cancer Vision Goggles and standard fluorescence imaging systems: -Member of the operating team will wear the CVG during surgery Surgery: -Standard of care
Number of Participants Receiving Optimal Imaging Dose of LS301 (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 (at the time of surgery)

Population: Data not collected for this outcome specific for phase II since study was terminated and did not proceed beyond phase 1a.

-The histopathological results of margin positivity has the following possible results: margin negative, margin positive at LS301 and CVG identified locations, margin positive at LS301 and CVG unidentified locations. Using LS301 and CVG, the exercised tissue will be considered to be margin positive and have ink marked at the identified locations if any positive margins are observed; otherwise, the margin is considered negative. Diagnostic test characteristics (sensitivity and specificity) of LS301 and CVG for margin positivity by histology will established and margin positivity rate, defined as the proportion of tumors with histopathologically confirmed positive margins but missed by CVG, will be estimated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 hours post LS301 injection

Population: Data not collected for this outcome specific for phase II since study was terminated and did not proceed beyond phase 1a.

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.