LS301 Uptake in Tumors of Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy for Breast Cancer
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/28/2018 |
| Start Date: | March 31, 2019 |
| End Date: | May 31, 2021 |
| Contact: | Julie Margenthaler, M.D. |
| Email: | margenthaler@wustl.edu |
| Phone: | 314-362-7534 |
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.
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.
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. We do not expect many of these adverse
reactions with LS301 because it is not radioactive and does not possess iodinated
counterions.
- 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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Julie Margenthaler, M.D.
Phone: 314-362-7534
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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