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NCT Number: NCT06982976

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

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.

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Key information

Conditions

Precancerous Cervical Lesion

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Unniversity Third Hospital

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Qin Han

CONTACT

[email protected]

13810632686

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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；

Treatment and study plan

ALA-PDT

Procedure

use ALA_PDT to treat the disease

Primary outcomes

  1. Efficacy of the treatment

    Time frame: 1 month after 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qin Han

CONTACT

[email protected]

13810632686

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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