Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia

Peking University

Status: Enrolling

Conditions: Precancerous Cervical Lesion

Treatments: Procedure: ALA-PDT

Study type: Interventional

Funder types: Other

Identifiers

NCT06982976

IRB00006761-M2023505

2022YFB3604704 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

ALA-PDT

Other group

Description:

Patients choose PDT to treat the disease

Treatment:

Procedure: ALA-PDT