Nerve-Sparing Gynecologic Surgery Enabled by A Near-Infrared Nerve-Specific Fluorophore Using Existing Clinical...

Area of Science:

• Surgical Innovation
• Medical Imaging
• Neuroanatomy

Background:

• Gynecological procedures often result in intraoperative nerve damage, leading to persistent side effects like incontinence and sexual dysfunction.
• The complex female pelvic neuroanatomy presents challenges for nerve-sparing surgical techniques.
• Current methods lack real-time visualization of critical nerves during surgery.

Purpose of the Study:

• To formulate and characterize a near-infrared (NIR) fluorescent nerve-specific contrast agent, LGW08-35.
• To evaluate the safety and efficacy of LGW08-35 for real-time nerve identification in gynecological surgery.
• To enable improved nerve-sparing strategies and reduce post-operative complications.

Main Methods:

• Formulation and characterization of micelle-encapsulated LGW08-35.
• Toxicology, pharmacokinetic (PK), and pharmacodynamic (PD) studies to determine optimal imaging parameters and maximum tolerated dose (MTD).
• In vivo imaging of female rat and swine pelvic neuroanatomy using the developed contrast agent.

Main Results:

• Successful formulation and characterization of LGW08-35 for compatibility with clinical fluorescence guided surgery (FGS) systems.
• Determination of optimal imaging doses, time points, and safety profile (MTD) through PK/PD studies.
• Validation of LGW08-35 for real-time visualization of key pelvic nerves (femoral, sciatic, lumbar, iliac, hypogastric) in animal models.

Conclusions:

• LGW08-35 is a promising nerve-specific contrast agent for intraoperative visualization in gynecological surgery.
• This agent facilitates real-time identification of critical nerves, supporting nerve-sparing techniques.
• Further clinical development of LGW08-35 can significantly improve surgical outcomes and patient quality of life by minimizing nerve damage.