Clinical Trial: Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

Brief Summary: The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Detailed Summary:

Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.

In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.


Sponsor: Photocure

Current Primary Outcome: Complete Response Rate [ Time Frame: 6 month ]

Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.


Original Primary Outcome: Lesion eradication [ Time Frame: 4 month ]

Current Secondary Outcome:

  • Eradication of HPV [ Time Frame: 6 months ]
    High risk HPV
  • Incidence of Patients With Adverse Events [ Time Frame: 3 months ]


Original Secondary Outcome: Eradication of lesion and HPV [ Time Frame: 4 and 12 months ]

Information By: Photocure

Dates:
Date Received: July 1, 2008
Date Started: January 2009
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013