Full Title
Phase I Trial of Real-Time Intraoperative Fluorescent Imaging of Nerve Structures Using Illuminare-1, A Novel Myelin-Binding FluorophorePurpose
During prostate cancer surgery, the surgeon removes all or part of the prostate gland as well as any nearby lymph nodes that may contain cancer cells. A nerve in the area where the cancer is being removed may be damaged accidentally, which may cause numbness, tingling, sharp pain, and weakness in the affected area and impair quality of life.
Currently, there are no approved ways to enhance the visual identification of nerves during surgery and surgery is usually performed without imaging guidance, using only the naked eye or magnifying techniques to see the area of the body where the surgery is being performed. Clear visualization of the nerves during surgery could limit the extent of the procedure and prevent nerve injury.
In this study, researchers are evaluating a fluorescent (glowing) imaging agent called Illuminare-1 during surgery to determine if it may help surgeons see the nerves more clearly and prevent accidental nerve injury. Investigators will identify the best dose of Illuminare-1 that allows nerve structures to be seen most easily while causing only few or manageable side effects. Illuminare-1 is given intravenously (by vein) during the surgery.
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must be planning to have minimally invasive prostate cancer surgery with lymph node removal.
- Patients may not have had prior pelvic surgery or pelvic radiation therapy.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Timothy Donahue at 646-422-4567.