- Source: Pegulicianine
Pegulicianine, sold under the brand name Lumisight, is an optical imaging agent. It is given via intravenous injection.
Pegulicianine was approved for medical use in the United States in April 2024.
Medical uses
Pegulicianine is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.
History
The efficacy and safety of pegulicianine were evaluated in a multicenter, intra-participant controlled clinical trial (NCT03686215) of participants with breast cancer undergoing lumpectomy surgery. A total of 357 participants underwent image-guided surgery with the Lumicell DVS following standard of care lumpectomy. When positive pegulicianine signal was detected, the tissue was resected with a cavity shave procedure. The study assessed the proportion of participants receiving pegulicianine who had residual cancer detected and removed after the standard of care lumpectomy. A total of 27 of 357 participants (7.6%) had cancer in at least one pegulicianine-guided shave. The study also assessed the image-level sensitivity (ability to designate an imaged region with disease as positive) and specificity (ability to designate an imaged region without disease as negative) for detection of cancer in the lumpectomy cavity. Sensitivity was 49.1% and specificity was 86.5%. Forty-three percent (43%) of participants had at least one false positive image and 8% of participants had at least one false negative image.
The FDA granted the application for pegulicianine fast track and priority review designations.
Society and culture
Pegulicianine is the international nonproprietary name.
References
External links
Clinical trial number NCT03686215 for "Investigation of Novel Surgical Imaging for Tumor Excision (INSITE)" at ClinicalTrials.gov
