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Search / Trial NCT07036614

The Novel Special Light for Endotracheal/Bronchial Lesions.

Launched by SHANGHAI CHEST HOSPITAL · Jun 17, 2025

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

Txi Nbi Rdi Wli

ClinConnect Summary

This is a single-center, observational study at Shanghai Chest Hospital in Shanghai, China. Researchers want to see if new imaging lights used during bronchoscopy (special lights called TXI, NBI, and RDI) can help doctors tell whether lesions inside the windpipe or airways are benign (not cancer) or cancerous. About 400 adults who already have endotracheal or bronchial lesions and need bronchoscopy may be invited to join. To participate, you’d need to be 18 or older, have findings on imaging suggesting a central lung lesion that needs bronchoscopy, and be able to consent and complete follow-up; people who are pregnant, have no lesion, or have other safety concerns for bronchoscopy would not be eligible.

Participants will undergo bronchoscopy using the new special lights along with standard light, to see how well these lights identify and classify lesions, with histopathology (tissue analysis) used as the gold standard for comparison. A secondary goal is to establish how to diagnose and grade lesions using the special lights. The main findings are planned to be evaluated within about one month after the procedure. This study is led by Dr. Jiayuan Sun at Shanghai Chest Hospital, and results will come from a real-world, diagnostic-focused approach rather than testing a new treatment. Enrollment started in 2024 and is ongoing, with an estimated completion by late 2026.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥18 years old;
  • 2. Patients with chest imaging findings indicating central lung lesions requiring further bronchoscopy;
  • 3. Patients with neoplasm in the lumen that could be biopsied by bronchoscopy or operated;
  • 4. Patient who has good compliance and sign informed consent;
  • 5. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.
  • Exclusion Criteria:
  • 1. Pregnant or lactating women;
  • 2. No endotracheal/bronchial lesions were detected by bronchoscopy;
  • 3. Allergic reaction to narcotic drugs in previous medical history;
  • 4. The investigator believes that the subject is not suitable for bronchoscopy;
  • 5. High-risk diseases or other special conditions for which the investigator considers the subjects unsuitable for clinical trials.

About Shanghai Chest Hospital

Shanghai Chest Hospital is a leading medical institution in China, renowned for its specialized expertise in respiratory and thoracic diseases. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical research and improving patient outcomes through innovative therapies and treatments. With a strong emphasis on collaboration and scientific rigor, Shanghai Chest Hospital actively engages in a variety of clinical trials aimed at exploring novel interventions and enhancing the understanding of pulmonary health. The hospital's state-of-the-art facilities and commitment to patient-centered care position it as a key player in the global research landscape.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Jiayuan Sun, MD, PhD

Study Director

Shanghai Chest Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported