Clinical trial Recruiting at 1 site Interventional Ages 18 to 65 Women only

Using light therapy to treat precancerous cervical and vaginal lesions

Official title: Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia:A Multicenter Prospective Cohort Study

Run by Peking University Third Hospital · NCT06982976 · Data updated 2026-11-12

This study is testing if light therapy can safely treat precancerous cervical and vaginal lesions in women with specific types of abnormal cells.

More Precancerous Cervical Lesion trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexWomen only
Enrollment250 (estimated)
SponsorPeking University Third Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedFebruary 28, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedMay 21, 2025
Trial IDNCT06982976 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women diagnosed with high-grade squamous intraepithelial lesions or persistent low-grade lesions who are willing to receive treatment.

Probably not a fit

Patients with confirmed cancer, severe medical comorbidities, or allergies to light therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of photodynamic therapy using 20% 5-amino-ketovalerate and 630nm red light for treating cervical and vaginal intraepithelial neoplasia in women. The approach focuses on patients with confirmed high-grade squamous intraepithelial lesions or persistent low-grade lesions who are willing to undergo treatment. The study aims to gather real-world data on the treatment's effectiveness and safety profile.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for women with precancerous cervical and vaginal lesions, potentially reducing the need for more invasive procedures.

How similar studies have gone: While photodynamic therapy has been explored in various contexts, this specific application for cervical and vaginal intraepithelial neoplasia is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* cervical/vaginal high-grade squamous intraepithelial lesions (HSILs) confirmed by colposcopy and pathological biopsy (CIN2 /CIN3 and/or VaIN2/ VaIN3) or persistent CIN1/VaIN1 lasting for more than one year with a strong willingness to treat;
* colposcopy was adequate, and analysable colposcopy images were retained;
* endocervical curettage (ECC) did not suggest higher-grade lesions.

Exclusion Criteria:

* coexistence or suspicion of cancer;
* porphyria or suspected allergies to red and blue light;
* severe medical comorbidities;

Where it's running

  • Peking Unniversity Third Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.