Cervical Dysplasia
Conditions
Keywords
photodynamic therapy, methyl aminolevulinate, hexaminolevulinate, dose-finding, cervical dysplasia
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.
Interventions
DRUGmethyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
Sponsors
Photocure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion eradication | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Eradication of lesion and HPV | 6 and 12 months |
| Safety assessment | 6 months |
Countries
Germany, Norway
Outcome results
None listed