Clinical Trials

Sponsor(s): PhotoCure

Condition(s):

Cervical Cancer
Cervical Dysplasia
Cancer
Cervical Intraepithelial Neoplasia
Neoplasms

Purpose: The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Eligibility:

Minimum Age:

18 Years

Accepts Healthy Volunteers:

No

Inclusion Criteria:

- 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 Criteria:

- 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

- Patients who have received one or more shots of a prophylactic HPV vaccine
(e.g.Gardasil or Cervarix)

- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate
or aminolevulinic acid)

- 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.

Other Location(s): Lille, France,Hannover, Germany,Oslo, Norway

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.