Status:
TERMINATED
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
Lead Sponsor:
Photocure
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
Detailed Description
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 spon...
Eligibility Criteria
Inclusion
- Satisfactory colposcopy examination
- Negative endocervical canal by colposcopy
- Ectocervical CIN1 as verified by local pathologist (biopsy).
- Colposcopical visible lesion at visit 2, before photoactivation
- Written Informed Consent signed
- Age 18 or above
Exclusion
- Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
- Malignant cells on cytology or histology
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
- Suspicion of endocervical disease on colposcopy
- Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination
- Known or suspected porphyria
- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- Use of heart pacemaker
- Pregnancy
- Nursing
- Childbirth or miscarriage within six weeks of enrolment - Known
- Participation in other "competitive" clinical studies either concurrently or within the last 30 days
- Risk of poor protocol compliance
- Not willing to use adequate birth control from screening until last PDT
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00708942
Start Date
January 1 2009
End Date
January 1 2012
Last Update
April 24 2013
Active Locations (5)
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1
Department of Obstetrics and Gyneacology, Lille University Hospital
Lille, France
2
Department of Obstetrics and Gynecology
Hanover, Germany
3
Fritzøe klinikk
Larvik, Norway
4
Department of Obstetrics and Gynaecology, Ullevål University Hospital
Oslo, Norway