Status:
RECRUITING
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia
Lead Sponsor:
Peking University Third Hospital
Conditions:
Precancerous Cervical Lesion
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical and vaginal intraepithelial neoplasia in women in the real world.
Eligibility Criteria
Inclusion
- 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
- coexistence or suspicion of cancer;
- porphyria or suspected allergies to red and blue light;
- severe medical comorbidities；
Key Trial Info
Start Date :
February 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06982976
Start Date
February 28 2025
End Date
December 31 2028
Last Update
May 21 2025
Active Locations (1)
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1
Peking Unniversity Third Hospital
Beijing, Beijing Municipality, China, 100191