Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
18 Years
N/A
Female
Cervical Dysplasia
Trial Information
Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
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.
Inclusion Criteria:
- Positive histology of CIN 1-3
Exclusion Criteria:
- Patients with endocervical lesions
- Patients with AGUS
- Patients with invasive disease
- Patients with porphyria
- Patients sensitive to MAL and HAL
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Lesion eradication
Outcome Time Frame:
6 months
Principal Investigator
Peter Hillemanns, Md PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hannover Medical School
Authority:
Norway: Norwegian Medicines Agency
Study ID:
PC CE101/06
NCT ID:
NCT00369018
Start Date:
August 2006
Completion Date:
July 2009
Related Keywords:
- Cervical Dysplasia
- photodynamic therapy
- methyl aminolevulinate
- hexaminolevulinate
- dose-finding
- cervical dysplasia
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia
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