Clinical Trials Search
Clinical Trial 19237
Study Type: Treatment
Phase of Study: Phase II
- Marie Lee
An Open-Label, Single-Arm, Phase 2 Study Of Avb-620 In Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
This study is being done to learn more about an experimental drug called AVB-620 Sterile Solution (also called "AVB-620"). AVB-620 is being developed to help doctors find cancer in the body during surgery (for example, breast cancer). This study is being done to find out if AVB-620 and a special imaging Camera System can help the surgeon detect additional breast cancer during surgery and possibly reduce the need for additional surgery later.
Primary: To determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients. Secondary: To identify the malignant tissue types (eg, lymph nodes, primary tumor) in breast cancer that provide the most robust fluorescence response compared to nonmalignant tissue. To further evaluate the effect of timing of AVB-620 administration (day of surgery versus day before surgery) relative to surgery on optical fluorescence characteristics. To evaluate the safety and tolerability of a single AVB-620 infusion in women with primary, nonrecurrent breast cancer undergoing surgery. Exploratory: To evaluate the impact of changes in imaging techniques and conditions in distinguishing malignant tissue from nonmalignant tissue. To evaluate and refine methods and criteria by which images are analyzed and displayed. To evaluate which breast cancer patients are most suitable for AVB-620 imaging. To determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.