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HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2

NCT07634497 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-06-16

No results posted yet for this study

Summary

This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-06-15
Completion
2029-12-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634497 on ClinicalTrials.gov