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

NCT06982976 | Recruiting DMC

• 2 other identifiers: IRB00006761-M20235052022YFB3604704
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Precancerous Cervical Lesion

Keywords

ALA-PDT; HPV; CIN; VAIN

Outcome Measures

Primary Outcomes (1)

• Efficacy of the treatment

  colposcopy and biopsy will be performed one month after the treatment. Patients will be categorised as having complete remission(CR) if biopsy confirmed LSIL. If CIN 2/VAIN 2 was found after the first course of PDT, it would be categorised as partial remission(PR) if they are CIN3/VAIN3 before treatment. Those with the same grade were categorised as persistent disease(PD). The proportion of CR and PR after PDT treatment.

  1 month after the treatment

Study Arms (1)

ALA-PDT

OTHER

Patients choose PDT to treat the disease

Procedure: ALA-PDT

Interventions

ALA-PDT PROCEDURE

use ALA\_PDT to treat the disease

ALA-PDT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Unniversity Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Qin Han

CONTACT

13810632686; Lmlfe_lyn@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 21, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-03

Locations

CN (1)