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1 Study Matches

Feasibility Study Phase C: Expansion in 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

The main goal of standardizing the training for surgeons and clinical staff that will be participating in the anticipated pivotal study of the Lumicell Imaging System. Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer patients and to collect safety and efficacy data.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02438358
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Inclusion Criteria:
Female, age of 18 years or older
Cytology confirmed primary invasive breast cancer, ductal carcinoma in situ or a combination of both
Scheduled for lumpectomy for a breast malignancy
No uncontrolled serious medical problems
Exclusion Criteria:
Subjects who are pregnant at the time of breast cancer diagnosis
Uncontrolled hypertension or other uncontrolled medical problems
Patient who is sexually active and not willing to use contraception-hormonal or barrier method, or abstinence for 60 days after injection
Individuals undergoing a second lumpectomy because of previous positive margins
Subjects who have taken an investigational drug in the 30 days prior to enrollement
Cancer, Women's Health
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Study Locations

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Location
Hershey, PA