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Fluorescence Imaging Agent
Fluorescence Imaging for Breast Cancer Surgery
Phase 1 & 2
Recruiting
Led By Julie Margenthaler, M.D.
Research Sponsored by Samuel Achilefu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of enrollment of all phase i participants (estimated to be 18 months)
Awards & highlights
Study Summary
This trial will use a new fluorescence imaging agent, LS301, to help surgeons more accurately remove all cancer cells during surgery for breast cancer.
Who is the study for?
This trial is for adults over 18 with newly diagnosed Stage I-II breast cancer, planning to have breast-conserving therapy and SLN biopsy. They must understand and sign consent. Excluded are breastfeeding or pregnant women, those unfit for surgery, on other trials, with lung disease or allergies to study agents like ICG.Check my eligibility
What is being tested?
The trial tests Cancer Vision Goggles (CVG) combined with LS301 dye during surgery to see if they can better identify cancer cells and reduce positive margins in breast cancer surgeries. Phase 1 checks safety/dose of LS301; Phase 2 assesses its ability to detect cancer at surgical margins.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to those seen with iodine-based dyes or seafood allergies due to the use of LS301 dye in the procedure. However, since LS301 isn't radioactive nor contains iodinated ions, fewer adverse reactions are expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of enrollment of all phase i participants (estimated to be 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of enrollment of all phase i participants (estimated to be 18 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of LS301 to predict presence of positive margins around partial mastectomy (Phase II)
Optimal imaging dose of LS301 (Phase I)
Safety of LS301 in breast as measured by related adverse events (Phase I)
Secondary outcome measures
Toxicity of LS301 in breast as measured by related adverse events (Phase II)
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase II: LS301Experimental Treatment3 Interventions
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.
Group II: Phase I Dose Level 3: LS301Experimental Treatment3 Interventions
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.
Group III: Phase I Dose Level 2: LS301Experimental Treatment3 Interventions
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.
Group IV: Phase I Dose Level 1: LS301Experimental Treatment3 Interventions
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.
Group V: Phase I Dose Expansion: LS301Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
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Who is running the clinical trial?
Samuel AchilefuLead Sponsor
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,659 Total Patients Enrolled
46 Trials studying Breast Cancer
5,071 Patients Enrolled for Breast Cancer
Julie Margenthaler, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Breast Cancer
81 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- No signs of enlarged lymph nodes during a physical examination.I cannot have surgery due to health risks.I am not pregnant and have a recent negative pregnancy test.I have a lung condition.I do not have allergies to ICG, iodide, seafood, or study agents.I am 18 years old or older.I have early-stage breast cancer and am getting a lumpectomy and sentinel lymph node biopsy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I Dose Level 1: LS301
- Group 2: Phase I Dose Expansion: LS301
- Group 3: Phase I Dose Level 2: LS301
- Group 4: Phase II: LS301
- Group 5: Phase I Dose Level 3: LS301
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many total subjects are in this experiment?
"Yes, this is an ongoing study that was originally posted on February 18th, 2020. The most recent update to the listing was on August 29th, 2022. They are looking for 97 participants total, at 2 different medical sites."
Answered by AI
Are there still opportunities for people to participate in this research project?
"That is correct. The information available on clinicaltrials.gov affirms that this trial, which was initially posted on February 18th 2020, currently has open enrolment. There are 97 total spots for participants at 2 different locations."
Answered by AI
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