Breast CancerPhase 1/2NCT02807597
Real-time Intraoperative Breast Cancer Visualization for Margin Assessment
A Phase 1/2 study testing LS301, Cancer Vision Goggles and standard fluorescence imaging systems and Surgery in people with Breast Cancer and Cancer of the Breast, run by Samuel Achilefu at 1 site in United States.
Trial summary
The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- LS301, Cancer Vision Goggles and standard fluorescence imaging systems and Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 27 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed Stage I-II breast cancer patients undergoing breast-conserving therapy and SLN biopsy.
- Negative nodal basin clinical exam.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
Who cannot join
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. The investigators do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counter ions.
- Presence of underlying lung disease
- Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
- Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LS301.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of LS301 Uptake in Tumors of Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy for Breast Cancer
The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of breast cancer patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 20%. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.
Phase 1: to determine the safety and optimal imaging dose of LS301 injected in breast cancer patients.
Phase 2: to determine the ability of this novel fluorescence imaging agent to predict the presence of positive margins around partial mastectomy specimens and positive SLNs during surgical therapy for breast cancer.
Read the detailed description
A rolling six design which is intended for relatively safe trials and shortening the study duration is proposed for the phase 1 portion 74. In the rolling six design, three to six patients can be enrolled to a dose each time. The dose de-escalation occurs when two or more DLT occur at a dose level while dose escalation occurs when 3/3, 4/4, 5/5, 5/6 or 6/6 patients are evaluated without DLT 75. Three dose levels will be tested in the phase I study, 0.05, 0.075 and 0.10 mg/kg. LS301 will be administered intravenously at a starting dose of 0.05 mg/kg to a cohort of six patients and escalate/de-escalate following the decision rule of the rolling six design. Once six patients have been included at the current dose level, inclusions are suspended until at least five of the six patients have completed the procedure without DLT observed in the evaluation period. MTD is hit where two or more patients out of six at a dose level experience DLT. The investigators do not expect any serious adverse events related to LS301 at the initial Dose Level 1. Once the MTD is determined, an expansion cohort with 9 patients will be tested at the MTD and an optimal imaging dose will be recommended for the subsequent phase II trial.
At the completion of the expansion cohort, a single arm phase 2 trial will be performed at the optimal imaging dose. A breast surgeon will perform breast conserving surgery per standard of care. At the completion of the surgery, a second investigator (to reduce bias in data collection) will wear the cancer vision goggle (CVG) to visualize the excised tissue to determine if there are any positive margins based on the presence of LS301 fluorescence. If any positive margins are observed, the subject will be considered to have a positive margin; otherwise, the margin is considered negative. The excised tissue will later be examined by a breast cancer pathologist. Standard pathologic techniques will be used to determine if there are positive margins. Particular attention will be paid to the sites marked following CVG assessment to confirm whether the margin is positive or negative at any of these sites, or positive at other locations not identified by CVG. No interventions will be allowed based on the CVG results.
This study was initiated at Washington University in St. Louis and is being transferred to UTSW. Phase 1a was initiated at Washington University in St. Louis where 9 subjects were enrolled. The PI is continuing with Phase 1B at UTSW where 9 more subjects will be enrolled. Once completed, the results of Phase 1 (a and b) will be sent to the FDA for review. Phase II will begin once the FDA has reviewed the interim data and authorized Phase II to open. After phase 1 data has been submitted to and discussed with the FDA, an additional cohort of 88 patients will be enrolled to the phase 2 portion of the trial to assess the diagnostic capabilities of LS301 for identification of positive margins at surgery. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- LS301, Cancer Vision Goggles and standard fluorescence imaging systems, Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS301Drug
-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 systemsDevice
Also called CVG
-Member of the operating team will wear the CVG during surgery
SurgeryProcedure or surgery
-Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Level 1: LS301 | Experimental | * 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. Receives: Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery |
| Phase I Dose Level 2: LS301 | Experimental | * 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. Receives: Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery |
| Phase I Dose Level 3: LS301 | Experimental | * 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. Receives: Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery |
| Phase I Dose Expansion: LS301 | Experimental | * 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. Receives: Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery |
| Phase II: LS301 | Experimental | * 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. Receives: Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Related Adverse Events of LS301 in Breast (Phase I)
-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.
Measured: Time of injection to 3 hours post-injection
Number of Participants Receiving Optimal Imaging Dose of LS301 (Phase I)
- 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
Measured: 14-15 months
Ability of LS301 to Predict Presence of Positive Margins Around Partial Mastectomy (Phase II)
-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.
Measured: Day 1 (at the time of surgery)
Secondary outcomes (1)
Toxicity of LS301 in Breast as Measured by Related Adverse Events (Phase II)
-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.
Measured: up to 48 hours post LS301 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start18 Feb 2020
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Why it stopped: Before LS301's licensing and reformulation, 9 patients received LS301-HSA (Phase 1a) , but since no patients were recruited (in Phase 1b) before the product expired, this study has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A rolling six design will be used to enroll patients in the phase I dose escalating portion of the study.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Achilefu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samuel Achilefu, University of Texas Southwestern Medical Center
- Investigators
- Samuel Achilefu, Ph.D., Principal investigator, University of Texas Southwestern Medical CenterDeborah Farr, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807597
- Sponsor's protocol ID
- STU-2022-0385
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2016
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of LS301 Uptake in Tumors of Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02807597
- Acronym / sponsor ID
- STU-2022-0385
- Conditions
- Breast Cancer, Cancer of the Breast
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Before LS301's licensing and reformulation, 9 patients received LS301-HSA (Phase 1a) , but since no patients were recruited (in Phase 1b) before the product expired, this study has been terminated.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Samuel AchilefuUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of breast cancer patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 20%. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.
Phase 1: to determine the safety and optimal imaging dose of LS301 injected in breast cancer patients.
Phase 2: to determine the ability of this novel fluorescence imaging agent to predict the presence of positive margins around partial mastectomy specimens and positive SLNs during surgical therapy for breast cancer.
Detailed description
A rolling six design which is intended for relatively safe trials and shortening the study duration is proposed for the phase 1 portion 74. In the rolling six design, three to six patients can be enrolled to a dose each time. The dose de-escalation occurs when two or more DLT occur at a dose level while dose escalation occurs when 3/3, 4/4, 5/5, 5/6 or 6/6 patients are evaluated without DLT 75. Three dose levels will be tested in the phase I study, 0.05, 0.075 and 0.10 mg/kg. LS301 will be administered intravenously at a starting dose of 0.05 mg/kg to a cohort of six patients and escalate/de-escalate following the decision rule of the rolling six design. Once six patients have been included at the current dose level, inclusions are suspended until at least five of the six patients have completed the procedure without DLT observed in the evaluation period. MTD is hit where two or more patients out of six at a dose level experience DLT. The investigators do not expect any serious adverse events related to LS301 at the initial Dose Level 1. Once the MTD is determined, an expansion cohort with 9 patients will be tested at the MTD and an optimal imaging dose will be recommended for the subsequent phase II trial.
At the completion of the expansion cohort, a single arm phase 2 trial will be performed at the optimal imaging dose. A breast surgeon will perform breast conserving surgery per standard of care. At the completion of the surgery, a second investigator (to reduce bias in data collection) will wear the cancer vision goggle (CVG) to visualize the excised tissue to determine if there are any positive margins based on the presence of LS301 fluorescence. If any positive margins are observed, the subject will be considered to have a positive margin; otherwise, the margin is considered negative. The excised tissue will later be examined by a breast cancer pathologist. Standard pathologic techniques will be used to determine if there are positive margins. Particular attention will be paid to the sites marked following CVG assessment to confirm whether the margin is positive or negative at any of these sites, or positive at other locations not identified by CVG. No interventions will be allowed based on the CVG results.
This study was initiated at Washington University in St. Louis and is being transferred to UTSW. Phase 1a was initiated at Washington University in St. Louis where 9 subjects were enrolled. The PI is continuing with Phase 1B at UTSW where 9 more subjects will be enrolled. Once completed, the results of Phase 1 (a and b) will be sent to the FDA for review. Phase II will begin once the FDA has reviewed the interim data and authorized Phase II to open. After phase 1 data has been submitted to and discussed with the FDA, an additional cohort of 88 patients will be enrolled to the phase 2 portion of the trial to assess the diagnostic capabilities of LS301 for identification of positive margins at surgery. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- A rolling six design will be used to enroll patients in the phase I dose escalating portion of the study.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Level 1: LS301 | Experimental | Drug: LS301, Device: Cancer Vision Goggles and standard fluorescence imaging systems, Procedure: Surgery* 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. |
| Phase I Dose Level 2: LS301 | Experimental | Drug: LS301, Device: Cancer Vision Goggles and standard fluorescence imaging systems, Procedure: Surgery* 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. |
| Phase I Dose Level 3: LS301 | Experimental | Drug: LS301, Device: Cancer Vision Goggles and standard fluorescence imaging systems, Procedure: Surgery* 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. |
| Phase I Dose Expansion: LS301 | Experimental | Drug: LS301, Device: Cancer Vision Goggles and standard fluorescence imaging systems, Procedure: Surgery* 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. |
| Phase II: LS301 | Experimental | Drug: LS301, Device: Cancer Vision Goggles and standard fluorescence imaging systems, Procedure: Surgery* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed Stage I-II breast cancer patients undergoing breast-conserving therapy and SLN biopsy.
- Negative nodal basin clinical exam.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
Key exclusion criteria (6 listed)
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. The investigators do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counter ions.
- Presence of underlying lung disease
- Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LS301-LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond. | Drug | Phase I Dose Expansion: LS301, Phase I Dose Level 1: LS301, Phase I Dose Level 2: LS301, Phase I Dose Level 3: LS301, Phase II: LS301 |
| Cancer Vision Goggles and standard fluorescence imaging systemsAlso: CVG-Member of the operating team will wear the CVG during surgery | Device | Phase I Dose Expansion: LS301, Phase I Dose Level 1: LS301, Phase I Dose Level 2: LS301, Phase I Dose Level 3: LS301, Phase II: LS301 |
| Surgery-Standard of care | Procedure or surgery | Phase I Dose Expansion: LS301, Phase I Dose Level 1: LS301, Phase I Dose Level 2: LS301, Phase I Dose Level 3: LS301, Phase II: LS301 |
Primary outcome
Number of Participants With Related Adverse Events of LS301 in Breast (Phase I)
Time frame: Time of injection to 3 hours post-injection
-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.
Number of Participants Receiving Optimal Imaging Dose of LS301 (Phase I)
Time frame: 14-15 months
* 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
Ability of LS301 to Predict Presence of Positive Margins Around Partial Mastectomy (Phase II)
Time frame: Day 1 (at the time of surgery)
-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.
1 secondary outcome
Toxicity of LS301 in Breast as Measured by Related Adverse Events (Phase II)
Time frame: up to 48 hours post LS301 injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Achilefu, Ph.D. principal investigator
University of Texas Southwestern Medical Center
Deborah Farr, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LS301, Cancer Vision Goggles and standard fluorescence imaging systems and Surgery in people with Breast Cancer and Cancer of the Breast, run by Samuel Achilefu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Related Adverse Events of LS301 in Breast (Phase I) (time frame: Time of injection to 3 hours post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.