A novel humanized ferritin-based near-infrared (NIR) fluorescent probe is under investigation for its potential to enhance the identification of tumor margins in gastric cancer patients. The diagnostic test, known as the ICG-FTn perfusion solution, is being spearheaded by Nanfang Hospital, Southern Medical University, according to the latest publicly released information. While recruitment for the clinical trial has not yet begun, its implications could significantly advance molecular imaging technologies in gastroenterology.
What changed?
The announcement revolves around a novel molecular imaging approach specifically targeted for gastric cancer diagnostics. With the introduction of the ICG-FTn perfusion solution, researchers aim to leverage its humanized ferritin-based formulation paired with near-infrared fluorescence for real-time identification of tumor boundaries. While the program is not yet recruiting as of December 11, 2025, it serves as a promising pivot within the field of personalized diagnostics for gastrointestinal oncology.
What is the ICG-FTn perfusion solution?
The ICG-FTn solution combines ferritin-based nanotechnology with the fluorescence properties of indocyanine green (ICG). Ferritin acts as a biocompatible carrier for the dye, enabling efficient delivery to targeted tumor tissues. Indocyanine green ensures enhanced near-infrared imaging, which has shown potential for providing high-contrast tumor visualization. This dual-action design supports better delineation of tumor margins, potentially reducing risks of residual cancerous tissues during surgery.
Sponsored by Nanfang Hospital, this experimental diagnostic tool represents a shift toward more patient-specific and real-time imaging solutions aimed at improving surgical outcomes.
Why does this approach matter?
Gastric cancer continues to pose challenges in terms of treatment efficacy partly due to incomplete tumor excision. By providing surgeons with precise, fluorescent-guided imaging of tumor borders, the ICG-FTn technology may help mitigate this issue and lower recurrence rates. It also streamlines workflows compared to traditional histology-based assessments.
What outcomes are expected?
Although this trial remains in its early stages, the intended outcomes focus on demonstrating safety, imaging specificity, and a clear safety profile in clinical applications. If successful, the findings may lay the groundwork for eventual regulatory approval and widespread adoption in clinical settings.
This trial underscores ongoing efforts to combine diagnostic and surgical innovations under a single molecular system. The results could affect regulatory pathways for optical molecular probes, emphasizing safety alongside clinical usability for improved patient outcomes.
How will the trial proceed?
As part of routine clinical trial processes, participants will undergo ethical screening before receiving the investigational diagnostic solution. Real-time imaging and post-surgical pathologies will likely serve as primary endpoints to evaluate the technology’s performance.
Frequently Asked Questions
-
What is the current status of the study?
The study is listed as “Not yet recruiting” as of December 11, 2025.
-
What conditions will this diagnostic test address?
The ICG-FTn perfusion solution is designed for identifying tumor margins in gastric cancer patients.
-
Who is conducting the study?
The trial is sponsored by Nanfang Hospital, Southern Medical University.
Conclusion
The ICG-FTn perfusion solution represents a new frontier in molecular imaging for gastric cancer. By combining advanced nanotechnology with fluorescent guidance, it aims to enhance the precision of tumor margin visualization. With recruitment still pending, stakeholders in oncology, diagnostics, and regulatory affairs should closely monitor this trial’s outcomes for broader implications in the field.
Disclaimer
This content is for informational purposes only and is not intended as regulatory or clinical advice. Readers should consult their organizations for specific guidance.
Announcement Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07276854?term=medical+device