Aurora St. Luke’s Medical Center in Milwaukee is the third site in the country to join a cancer clinical trial studying the viability of intraoperative, real-time fluorescence imaging to better guide surgeons during breast conserving surgery.
“During breast conserving surgery, surgeons try to completely remove tumor tissue while conserving as much of the surrounding healthy tissue as possible,” said surgical oncologist Nicole Zaremba, MD, Advocate Aurora Research Institute principal investigator for the study. “We do this by referencing radiology images taken before the surgery. Sometimes we can feel for the cancer during surgery, but most often tumors are too small to feel.”
Nationally, more than of 20% of the time, a patient’s cancer has spread beyond what the surgeon can see or feel using these methods. The only way for the surgeon to determine if the tumor tissue has been completely removed is to await microscopic pathologic review of the tissue. If that shows some cancer was left behind, additional surgery is necessary to remove all of the cancer.
“Re-excisions, or additional surgeries, increase the chance of complications and poor cosmetic outcomes, as well as medical costs,” Dr. Zaremba said. “This creates a clear clinical need for real-time visualization of tumor tissue during breast conserving surgery.”
The trial will evaluate the safety and effectiveness of the investigational drug PD G 506 A (aminolevulinic acid hydrochloride) and the investigational device Eagle V1.2 Imaging SystemTM for use in fluorescence imaging during breast lumpectomy surgery, the initial tumor-removal procedure. PD G 506 A is an oral solution that, after entering the body, is converted into a fluorescent molecule which gathers in breast cancer tissue. When blue light from the Eagle V1.2 handheld fluorescence imaging device shines on this breast cancer tissue, the fluorescent molecule produces red light that can be viewed in real time during surgery using the Eagle V1.2 Imaging System. The imaging system uses visible light during the surgery, and no ultraviolet light or radiation is used.
PD G 506 A has been approved by the U.S. Food and Drug Administration (FDA) for use in a different type of cancer surgery. Neither PD G 506 A nor the Eagle V1.2 Imaging System have been FDA-approved for use during breast cancer lumpectomy outside of this clinical trial.
The clinical trial is divided in to two parts. The first part is open-label, with all patients receiving the study drug and undergoing fluorescence imaging during surgery. The second part is randomized and placebo-controlled, meaning study participants will be randomly assigned to receive either the study drug or a placebo. Assignment to the study drug group includes use of the imaging system during surgery. Participants will not know whether they received the study drug or a placebo. Researchers plan to enroll approximately 420 participants in the study.
“Advocate Aurora Research Institute is excited to support clinical trials like this, which, by seeking to optimize surgical procedures, directly impact the lives of our patients with cancer,” said Katie Wozniak, director of clinical trials research for cancer at the Research Institute.
The study, “Fluorescence imaging of carcinoma during breast conserving surgery,” is sponsored by SBI ALApharma Canada Inc. (“SBI Canada,” Toronto, Canada), which developed the study’s handheld fluorescence imaging device and is affiliated with photonamic GmbH & Co KG. (Pinneberg, Germany), the company that developed the study drug PD G 506 A.
To learn more about Advocate Aurora’s research, visit aah.org/research.