A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Complete Response Rate
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Peter Hillemanns, MD, PhD
Medizinische Hochschule Hannover, Hannover, Germany
Norway: Norwegian Medicines Agency