Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy

Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy

Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.

Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Yonsei University

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nimotuzumab

Antineoplastic Agents, Immunological

Participants will receive an i.v. infusion of 50 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Participants will receive an i.v. infusion of 100 mg IRDye800CW-nimotuzumab. Participants will undergo lung cancer resection surgery 4-6 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on results from cohorts 1 and 2). Participants will undergo lung cancer resection surgery 1-3 days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

Participants will receive an i.v. infusion of 50 or 100 mg IRDye800CW-nimotuzumab (depending on cohorts 1 and 2). Participants will undergo lung cancer resection surgery 7+ days after infusion. Vitals, blood sample and urine sample will be collected before infusion for a baseline. Blood and vitals will be taken post infusion. Blood and urine samples will be collected on the day of surgery. Participants will be followed up for any adverse event until day 30 post administration

50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion

IRDye800CW-nimotuzumab

Ron Geyer, PhD

Ronald Geyer, PhD

Humphrey Fonge, PhD

Kris Barreto, PhD

Wendy Bernhard, PhD

The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.

Single center, open-label, phase I/II image-guided surgery study to assess the image quality of IRDye800CW-nimotuzumab during surgery

Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery

To identify the dose with the highest tumor fluorescence and TBR.

To identify the imaging time with the highest tumor fluorescence and TBR.

Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.

Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.

a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy	NCT01926743	Gastric Cancer	Near infrared f...	20 Years - 80 Years	Yonsei University
Evaluation of IRDye800CW-nimotuzumab in Lung Cancer Surgery	NCT04459065	Lung Cancer	IRDye800CW-nimo...	18 Years - 80 Years	University of Saskatchewan
Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy	NCT01926743	Gastric Cancer	Near infrared f...	20 Years - 80 Years	Yonsei University

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