Spots Global Cancer Trial Database for A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

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Trial Identification

Brief Title: A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Official Title: Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study

Study ID: NCT00369018

Conditions

Cervical Dysplasia

Interventions

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

Study Description

Brief Summary: The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

Detailed Description: Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients. This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.