|Principal Investigator/ Physician||Lynn Dyess, MD|
|Contact Email||MCI Clinical Trials|
Protocol: Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer
Inclusion Criteria: Histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or a combination of invasive breast cancer and DCIS. Subjects who had diagnostic surgical biopsies are excluded from participation. Female, age of 18 years or older. Scheduled for a lumpectomy for a breast malignancy. Able and willing to follow study procedures and instructions. Received and signed an informed consent form. No uncontrolled serious medical problems except for the diagnosis of cancer. Normal organ and marrow function within limits as defined below: Leukocytes > 3,000/mcL, Platelets > 75,000/mcL, total bilirubin within normal institutional limits, AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal, Creatinine ≤ 1.5 mg/dL or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. ECOG performance status of 0 or 1.
Exclusion Criteria: pregnant at the time of diagnosis of their breast cancer. Sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. Have taken an investigational drug within 30 days of enrollment. Prolonged QTc interval defined as greater than 480 ms. Will have administration of methylene blue or any blue dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device. Have not recovered from adverse events due to other pharmaceutical or diagnostic agents. Uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; subjects with known HTN should be stable within these ranges while under pharmaceutical therapy. History of anaphylactic reaction attributed to any contrast agent or drugs containing polyethylene glycol (PEG). Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements. HIV-positive individuals on combination antiretroviral therapy. Investigator feels participation is not in the best interest of the subject. Undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study. Prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants. Prior ipsilateral reduction mammoplasties (breast reductions) performed less than 2 years prior to enrollment to this study. Previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy
Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03321929?term=CL0006&rank=1
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