Using a new imaging agent during breast cancer surgery
An Open-label, Single-arm, Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of LS301-IT in Female Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma in Situ (DCIS) or Stage I-II Primary Invasive Breast Cancer
This study is testing a new imaging agent to help doctors see tumor edges and lymph nodes better during breast cancer surgery for women with early-stage breast cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Integro Theranostics Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Scottsdale, Arizona and 8 other locations) |
| Trial ID | NCT05900986 on ClinicalTrials.gov |
What this trial studies
This Phase 1b/2 study aims to evaluate the safety and effectiveness of LS301-IT, a novel fluorescence imaging agent, in female patients undergoing partial mastectomy for ductal carcinoma in situ (DCIS) or Stage I-II invasive breast cancer. The study will involve administering a single intravenous dose of LS301-IT to help visualize tumor margins and sentinel lymph nodes during surgery. The research will be conducted in two phases: the first focusing on dose finding and the second on expanding the sample size based on the optimal dosing regimen determined in the first phase. The study will assess safety as the primary objective, followed by efficacy through fluorescence imaging observations.
Who should consider this trial
Good fit: Ideal candidates include female patients with DCIS or Stage I-II primary invasive breast cancer who are scheduled for partial mastectomy and sentinel lymph node biopsy.
Not a fit: Patients with contraindications for surgery or those who have had prior treatments for their breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes by enhancing the visualization of tumor margins and lymph nodes, potentially leading to better cancer management.
How similar studies have performed: Other studies using fluorescence imaging agents in surgical oncology have shown promising results, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy. * ECOG performance status of 0 to 2 Exclusion Criteria: * Contraindications for surgery. * Simultaneous bilateral lumpectomies and bilateral partial mastectomies. * History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study * Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1. * Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT. * History of radiation therapy to the chest. * The lymphatic imaging agent ICG cannot be used prior to the partial mastectomy and SLNB procedures on the day of surgery.
Where this trial is running
Scottsdale, Arizona and 8 other locations
- Integro Theranostics Research Site #2 — Scottsdale, Arizona, United States (Active_not_recruiting)
- Integro Theranostics Research Site #12 — Washington, District of Columbia, United States (Recruiting)
- Integro Theranostics Research Site #9 — Weston, Florida, United States (Active_not_recruiting)
- Integro Theranostics Research Site #6 — Bronx, New York, United States (Active_not_recruiting)
- Integro Theranostics Clinical Research Site #8 — Winston-Salem, North Carolina, United States (Completed)
- Integro Theranostics Research Site #10 — Cleveland, Ohio, United States (Active_not_recruiting)
- Integro Theranostics Research Site #5 — Philadelphia, Pennsylvania, United States (Recruiting)
- Integro Theranostics Research Site #3 — Dallas, Texas, United States (Active_not_recruiting)
- Integro Theronostics Research Site #1 — Houston, Texas, United States (Active_not_recruiting)
Study contacts
- Study coordinator: Nicole Peterson
- Email: npeterson@kingdomcapital.com
- Phone: 314-325-1800
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.