Real-time imaging for breast cancer surgery
Evaluation of LS301 Uptake in Tumors of Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy for Breast Cancer
This study is testing a new imaging agent and special goggles to see if they can help doctors find and remove all cancer cells during breast surgery, aiming to improve patient outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT02807597 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a novel fluorescence imaging agent, LS301, in conjunction with Cancer Vision Goggles to enhance the detection of cancer cells during breast-conserving surgery. The study is divided into two phases: Phase 1 focuses on determining the safety and optimal dosage of LS301, while Phase 2 evaluates its effectiveness in identifying positive surgical margins. The goal is to reduce the rate of margin positivity in breast cancer surgeries from over 20% to less than 5%. The trial employs a rolling six design to efficiently assess safety and dosage levels in patients.
Who should consider this trial
Good fit: Ideal candidates include newly diagnosed Stage I-II breast cancer patients who are undergoing breast-conserving therapy and sentinel lymph node biopsy.
Not a fit: Patients with contraindications for surgery, those receiving investigational agents, or individuals with certain allergies or underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes for breast cancer patients by ensuring complete tumor removal and reducing the need for additional surgeries.
How similar studies have performed: While this specific approach is novel, similar studies using fluorescence imaging for surgical margin assessment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Achilefu, Ph.D. — UT Southwestern Medical Center
- Study coordinator: Deborah Farr, M.D.
- Email: Deborah.Farr@UTSouthwestern.edu
- Phone: 214/648-5890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.