To use as an optical imaging agent for the detection of cancerous tissue
FDA Approval: 4/17/2024
Research Synopsis
Lumisight (pegulicianine) is a novel imaging agent used in fluorescence-guided surgical techniques for improving outcomes in breast-conserving surgery.
A study published in JAMA Surgery (2022) involving 234 women demonstrated that pegulicianine helped in real-time identification of residual cancer, aiming to reduce the need for additional surgeries.
Intraoperative margin assessment with pegulicianine showcased minimal adverse reactions among participants during the trial, indicating a favorable safety profile.
A recent multicenter trial in NEJM Evidence (2023) highlighted the effectiveness of pegulicianine combined with an optical device to enhance surgical precision by targeting lumpectomy margins.
The trials aim to address challenges like incomplete tumor removal, which can lead to local recurrence and necessitate further surgeries.
Despite some success in avoiding additional surgeries, the overall sensitivity of pegulicianine fluorescence-guided surgery was lower than expected.
However, it still met specificity benchmarks, confirming its relevance in identifying cancerous tissue.
Researchers continue to explore the potential of pegulicianine to improve surgical outcomes and reduce recurrence rates in breast cancer treatment.
As of October 2023, research indicates a positive sentiment around pegulicianine's role in enhancing surgical techniques, although additional refinement and studies may be necessary to fully realize its potential.
Further investigations are encouraged to optimize the use of pegulicianine to overcome its current limitations in sensitivity.
The study investigates a new imaging technique called pegulicianine fluorescence-guided system (pFGS) to improve outcomes in breast-conserving surgery (BCS) by identifying remaining cancer in real-time.
Conducted across 16 centers, 234 eligible women participated, receiving pegulicianine before surgery, with a focus on safety and efficacy data during a follow-up period.
Results showed that the majority of participants completed the trial with minimal adverse reactions, aiming to reduce the need for further surgery and improve surgical precision.
The advancement of fluorescence imaging in cancer surgery allows for enhanced surgical precision with intraoperative devices.
A multicenter trial by Smith et al. tested intravenous pegulicianine combined with an optical device to identify cancerous lumpectomy margins during surgery.
This method aims to reduce the need for additional surgeries by immediately excising cancerous tissue identified during the operation.
Lumpectomy and mastectomy have similar survival rates for breast cancer patients, but incomplete tumor removal indicated by positive lumpectomy margins can lead to local recurrence and increased mortality, often requiring a second surgery.
A clinical trial was conducted to determine the effectiveness of pegulicianine fluorescence-guided surgery (pFGS) in identifying cancerous margins during lumpectomy for various breast cancer stages, where patients were randomly assigned to pFGS or control groups to evaluate margin status.
Results showed that pFGS successfully identified residual tumors in some cases, avoiding second surgeries for some patients with positive margins; however, the overall sensitivity of pFGS was lower than hoped despite meeting specificity and successfully removing some remaining cancer.
Lumisight (pegulicianine)
Lumisight table: an interactive view-dependent tabletop display.
Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence-Guided System: A Nonrandomized Controlled Trial.
London, UK
2 hours ago
1 Received
The study investigates a new imaging technique called pegulicianine fluorescence-guided system (pFGS) to improve outcomes in breast-conserving surgery (BCS) by identifying remaining cancer in real-time.
Conducted across 16 centers, 234 eligible women participated, receiving pegulicianine before surgery, with a focus on safety and efficacy data during a follow-up period.
Results showed that the majority of participants completed the trial with minimal adverse reactions, aiming to reduce the need for further surgery and improve surgical precision.
Something to Dye For: Toward Better Breast Lumpectomy Margins.
London, UK
2 hours ago
1 Received
The advancement of fluorescence imaging in cancer surgery allows for enhanced surgical precision with intraoperative devices.
A multicenter trial by Smith et al. tested intravenous pegulicianine combined with an optical device to identify cancerous lumpectomy margins during surgery.
This method aims to reduce the need for additional surgeries by immediately excising cancerous tissue identified during the operation.
Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery.
London, UK
2 hours ago
1 Received
Lumpectomy and mastectomy have similar survival rates for breast cancer patients, but incomplete tumor removal indicated by positive lumpectomy margins can lead to local recurrence and increased mortality, often requiring a second surgery.
A clinical trial was conducted to determine the effectiveness of pegulicianine fluorescence-guided surgery (pFGS) in identifying cancerous margins during lumpectomy for various breast cancer stages, where patients were randomly assigned to pFGS or control groups to evaluate margin status.
Results showed that pFGS successfully identified residual tumors in some cases, avoiding second surgeries for some patients with positive margins; however, the overall sensitivity of pFGS was lower than hoped despite meeting specificity and successfully removing some remaining cancer.