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The U.S. Food and Drug Administration (FDA) today approved an imaging drug called Cytalux (pafolacianine), which is attracted to ovarian cancer tissue and illuminates it when exposed to fluorescent lights, allowing surgeons to more easily Discover and remove cancer more precisely. Doctors at the Precision Surgery Center at the Abramson Cancer Center at the University of Pennsylvania collaborated with the On Target laboratory in Indiana to lead one of the country's largest drug clinical trial centers. This method brings new hope to patients diagnosed with ovarian cancer, about half of which will relapse after initial treatment. Researchers at the University of Pennsylvania have pioneered targeted technologies for lung cancer, brain cancer, and urinary tract cancer.
Only 20% of ovarian cancers are detected early because there are usually no symptoms — or they may be similar to other common bladder, bowel, or gastrointestinal problems — and there are no screening tests like breast and cervical cancer. By the time most women are diagnosed, the disease has progressed, including spreading to organs in the abdominal cavity. Most patients then require surgery-also called cytoreductive surgery or cytoreductive surgery -; working to remove the tumor, as well as receiving chemotherapy.
"Illuminating cancer, which helps to identify lesions that may be difficult to detect—especially in the presence of scar tissue or other organ damage—can more completely identify and surgically remove cancer that might otherwise have been missed," Janos said L. Tanyi, MD, associate professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania, and lead investigator of Phase 2 and Phase 3 studies at the University of Pennsylvania Clinical Trial Center. "This FDA approval is expected to improve the prognosis of patients with ovarian cancer who are at high risk of recurrence after initial treatment."
In the randomized, multicenter phase 3 study, among the 134 adult women who received the diagnostic Cytalux (preoperative intravenous injection) and evaluated under normal and fluorescent lights, nearly 27% detected at least one cancerous lesion during surgery During the process, it was not found by standard inspection of vision or touch.
By using new technology to illuminate the tumor, surgeons have a guide that allows them to go beyond what they see or feel with the naked eye, especially when the lesion is small. This not only provides greater precision in removing cancerous lesions, but also protects healthy tissues. The newly approved dye can also help surgeons find cancerous lymph nodes.
Dr. Sunil Singhal, MD, Director of the Center for Precision Surgery at Abramson Cancer Center and Professor of Surgical Research William Maul Measey, began looking for a targeted method to visualize rogue cancer cells more than a decade ago, which is beyond the scope of surgeons. Feel it with the naked eye or with your fingers. The answer will come from his research on tumor permeability and small molecule retention. The difference between this reagent and the prior art is that it can selectively target cancer cells with a fluorescent contrast agent. Since 2012, Dr. Singhal has continued to explore this hypothesis in clinical studies involving more than 1,000 patients at the University of Pennsylvania. His research on Cytalux started with pre-clinical research, followed by human research. Eventually, the University of Pennsylvania and the Center for Precision Surgery became the leaders of Phase 1, Phase 2, and Phase 3 clinical trials. This research series may now constitute the world's largest clinical experience of intraoperative molecular imaging and targeted fluorescent dyes.
By using fluorescent dyes that bind to cancer cells to make them glow during surgery, surgeons can identify and remove as many tumors as possible and improve the prognosis. At every step of their treatment, we hope to help patients get the best possible results. This method is an important step to achieve higher accuracy in a series of different cancer operations. "
Sunil Singhal, MD, Director of the Center for Precision Surgery at Abramson Cancer Center and Professor William Maul Measey of Surgery Research
Published in: Medical News | Women's Health News | Medical News
Tags: bladder, brain, cancer, cervical cancer, chemotherapy, clinical trials, diagnosis, eye, food, gynecology, imaging, lymph nodes, medicine, molecular imaging, molecular, obstetrics, ovarian cancer, preclinical, research, scars, surgery, tumors
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