A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
18 Years
N/A
Female
Cervical Intraepithelial Neoplasia
Trial Information
A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
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 spontaneously, but must be followed up with gynecological examinations to
ensure normalization. If further persistent disease and worsening to precancerous lesions
(CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where
the CIN lesions are.
In this research study we will evaluate a new non-surgical treatment for CIN1 using
hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a
medication and a specific type of light to activate the drug. HAL PDT selectively removes
CIN lesions while preserving normal tissue, thus this may be an alternative to frequent
gynecological consultations and local surgery that may have undesirable side effects.
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
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Complete Response Rate
Outcome Description:
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Outcome Time Frame:
6 month
Safety Issue:
No
Principal Investigator
Peter Hillemanns, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medizinische Hochschule Hannover, Hannover, Germany
Authority:
Norway: Norwegian Medicines Agency
Study ID:
PC CE201/08
NCT ID:
NCT00708942
Start Date:
January 2009
Completion Date:
January 2012
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Cervical intraepithelial neoplasia (CIN)
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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