Fluorescent Navigation Technology in Radical Resection of Pancreatic Cancer

NCT06168552 | Unknown Phase 1

• 1 other identifier: CISPD-6
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Resectable Pancreatic Adenocarcinoma

Keywords

resectable pancreatic cancer; Fluorescence navigation technology

Outcome Measures

Primary Outcomes (1)

• Accuracy and sensitivity of the imaging agent

  Accuracy and sensitivity of anti-EGFR antibody-IR800CW imaging technology of primary pancreatic lesions and metastatic lymph nodes in radical resection of pancreatic cancer

  1 month after enrolled

Study Arms (1)

Arm A

EXPERIMENTAL

The patient underwent Da Vinci robot or fluorescent laparoscopic-assisted radical resection of pancreatic cancer. The day before the operation, anti-EGFR antibody-IR800CW imaging agent was injected into the vein, and the fluorescence test was performed to evaluate the imaging of the primary lesions of the pancreas and the intra-abdominal lymph nodes. And to evaluate for the presence of imaging lesions in the liver, peritoneum, pelvic cavity, etc.

Diagnostic Test: Injection of fluorescent developer (anti-EGFR-IR800CW)

Interventions

Injection of fluorescent developer (anti-EGFR-IR800CW) DIAGNOSTIC_TEST

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily joined the study and signed the informed consent form; Age is greater than or equal to 18 years old (time for signing the informed consent form);
• Minimally invasive radical surgical resection can be performed after discussion and evaluation of hepatobiliary and pancreatic surgery;
• The patient and his family members volunteered to receive radical surgical resection of pancreatic cancer; Patients must have reliable contraception during the study and within 6 months after the study period;
• negative serum pregnancy / urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects;
• male subjects should agree to have contraception during the study and within 6 months after the end of the study period;

You may not qualify if:

• \. Combined diseases and medical history:
• Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
• Within 5 years, the subject had previous or both other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); with other malignant tumors, but the following two conditions were enroll: other malignant tumors treated with single surgery with R0 resection and no recurrence for 5 years; cured cervical carcinoma in situ, skin basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• \. There are surgical contraindications;
• \. Study Treatment-Related to:
• Previous history of severe allergy to macromolecular drugs, or allergy to known ingredients of EGFR injection;
• Chronic treatment with systemic hormones or other immunosuppressive agents (dose\> 10mg / day prednisone or other efficacy hormone) 28 days prior to the start of the study and continued hormone or immunosuppressive agents within 2 weeks after the first test administration, immunomodulators included: therapeutic vaccines, cytokine therapy, or subjects against CTLA 4,4-1BB, OX-40 (except for regular use, temporary);
• Active autoimmune diseases requiring systemic treatment (e. g., corticosteroids or immunosuppressants) occurred within 2 years prior to the initiation of study treatment. Alternative therapies (e. g. thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered as systemic therapy;
• \. According to the discretion of the investigator, subjects with serious hazards to subject safety or concomitant diseases completing the study, or no other reasons for the enrollment.

Sponsors & Collaborators

• Zhejiang University: lead

Central Study Contacts

Tingbo Liang, PhD

CONTACT

+86 19941463683; liangtingbo@zju.edu.cn

Yiwen Chen, MD

CONTACT

+86 15088682641; cherry0705@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share