Implementation
Introduction
In the era of precision medicine, there is a growing demand for highly sensitive and specific molecular probes for early disease diagnosis and therapeutic monitoring. Our project aims to develop an innovative bio-inspired fluorescent protein probe that significantly improves the accuracy and efficiency of tumor diagnosis and other diseases. The core technology is based on modifying human serum albumin (HSA) to act as a highly efficient carrier for NIR-II fluorescent dyes, enabling high specificity and sensitivity in imaging disease markers. The enhanced tissue penetration of NIR-II light is critical for imaging deep tissues, making it highly beneficial for imaging tumors and internal organs. The probe developed in our project can be applied in various clinical settings, such as cancer surgery navigation, vascular and lymphatic system imaging, drug delivery, therapy monitoring, and biomedical research.
Proposed Implementation
Target Users:
Clinical Doctors: The main users include surgeons and radiologists working in the fields of oncology, stroke, hepatobiliary tumors, and lymphedema at major hospitals. The probe will be utilized for preoperative diagnosis, intraoperative navigation, postoperative monitoring, and live imaging.
Research Institutions and Hospital Departments: The probe can assist clinical and research institutions in more effectively imaging and monitoring disease markers, particularly in applications involving the lymphatic system, the blood-brain barrier (BBB), and the blood-testis barrier (BTB).
Biotechnology Companies: The probe holds enormous commercial potential for biotechnology companies to develop new clinical products and diagnostic tools.
Application Scenarios:
Tumor Surgery Navigation and Rapid Detection: The probe can aid surgeons in real-time tumor boundary identification, rapid detection of tumor-infiltrating lymph nodes, and ensuring complete resection. We discussed the clinical application scenarios for liver, bile duct, and pancreatic tumor surgery navigation with Dr. Liang Xiao at Zhejiang University’s Sir Run Run Shaw Hospital and explored potential uses for ovarian and cervical cancer surgery with Dr. Songling Zhang at the First Hospital of Jilin University.
Neurological Disease Diagnosis: The probe can be used to diagnose and monitor stroke and other neurological diseases, especially by overcoming current difficulties in imaging the blood-brain barrier. We discussed potential applications in early stroke diagnosis with Dr. Yilong Wang at Beijing Tiantan Hospital and explored the use of the probe in animal models of stroke.
Lymphatic and Vascular Imaging: By enhancing imaging of the lymphatic system and vascular structures, the probe aids in diagnosing cardiovascular and lymphatic system diseases. We discussed the high-resolution imaging solutions for lymphedema with Dr. Jianshi Du and Dr. Dahai Liu at the Third Hospital of Jilin University, exploring its potential for long-term monitoring.
Basic Biomedical Research: The probe can also be used for high-resolution imaging in live animal studies, aiding researchers in understanding disease processes and drug effects. We discussed potential interdisciplinary collaborations and applications in the glymphatic system with Dr. Minghuan Wang at Tongji Hospital, Huazhong University of Science and Technology.
Real-World Implementation:
Production and Distribution: The recombinant HSA protein and CO-1080 dye can be produced at scale through partnerships with biopharmaceutical companies. Dr. Qiang Yan at Huzhou Central Hospital discussed multi-center cooperation for intraoperative rapid detection, and we considered expanding probe use across multiple medical institutions to facilitate widespread clinical implementation.
Clinical Collaboration and Promotion: The project has already established collaborations with multiple hospitals, including Tongji Hospital, Sir Run Run Shaw Hospital, and Beijing Tiantan Hospital. These collaborations cover a wide range of clinical applications, such as imaging the glymphatic system, tumor surgery navigation, and stroke diagnosis.
Safety and Regulatory Compliance:
Safety Evaluation: Comprehensive toxicological studies will be conducted to ensure the probe’s safety, particularly in scenarios involving long-term injections and high dosages. Extensive clinical trials will ensure that the probe is safe and effective for different clinical applications.
Regulatory Approval: The probe’s clinical applications will need approval from international regulatory bodies like the FDA or EMA, ensuring compliance with medical device and pharmaceutical standards in various countries.
Implementation Challenges:
Equipment Availability: The adoption of NIR-II imaging technology is still limited. To promote the probe’s use, collaborations with imaging equipment manufacturers are essential to make NIR-II imaging systems more accessible in hospitals. We discussed the probe’s application in jawbone defect repair imaging with Dr. Hongchen Sun at the Stomatological Hospital of Jilin University, and considered its potential use in dental applications.
Cost and Production Scale: While small-scale production is affordable, large-scale commercialization requires substantial funding and manufacturing facilities. Discussions with Dr. Tianmin Xu at the Second Hospital of Jilin University focused on cost control for using the probe in intraoperative rapid detection for gynecological tumors.
Clinical Adoption Barriers: The probe’s clinical adoption will require considerable time and resources to complete related literature, clinical trials, and regulatory approvals, ensuring compliance with diverse national medical standards.