NCT06168552

Fluorescent Navigation Technology in Radical Resection of Pancreatic Cancer

Exploratory Clinical Study of Fluorescent Navigation Technology Based on Anti-EGFR Antibody-IR800CW Novel Imaging Agent in Radical Resection of Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to design the prospective, exploratory, single center clinical study, using targeted EGFR fluorescence imaging agent (anti-EGFR-IR800CW) and fluorescent navigation technology, in its lymph node tracing, intraoperative tumor localization, accurate determination of resection margin, and explore its clinical significance in radical surgical resection of pancreatic cancer.

Detailed description

The overall prognosis of pancreatic cancer is poor. For resectable patients, adjuvant chemotherapy is performed after surgery, which has become the standard and standard treatment recommended by various guidelines. Preoperative neoadjuvant therapy is proved to improve the R0 resection rate and reduce the lymph node metastasis rate, thus prolonging the postoperative recurrence-free survival time and increasing the survival benefit of patients. But despite adequate preoperative and postoperative treatment, the patient benefit remains limited. In pancreatic cancer surgery, improving the R0 resection rate, increasing the positive lymph node resection rate, and accurately identifying small metastases to accurately stage, can improve the prognosis of patients to a certain extent. Therefore, this study intends to design the prospective, exploratory, single center clinical study, using targeted EGFR fluorescence imaging agent (anti-EGFR-IR800CW) and fluorescent navigation technology, in its lymph node tracing, intraoperative tumor localization, accurate determination of resection margin, and explore its clinical significance in radical surgical resection of pancreatic cancer.

Conditions

• Resectable Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Injection of fluorescent developer (anti-EGFR-IR800CW)	The patient underwent Da Vinci robot or fluorescent laparoscopy-assisted radical resection of pancreatic cancer, and anti-EGFR antibody-IR800CW imaging agent was injected in the day before surgery, and fluorescence detection was performed

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-06-15
• Completion: 2024-12-15
• First posted: 2023-12-13
• Last updated: 2023-12-13