Brief Title
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
Official Title
A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
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 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete Response Rate
Secondary Outcome
Eradication of HPV
Condition
Cervical Intraepithelial Neoplasia
Intervention
Hexaminolevulinate (HAL)
Study Arms / Comparison Groups
1
Description: HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
83
Start Date
January 2009
Completion Date
January 2012
Primary Completion Date
January 2012
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Peter Hillemanns, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00708942
Organization ID
PC CE201/08
Responsible Party
Sponsor
Study Sponsor
Photocure
Study Sponsor
Peter Hillemanns, MD, PhD, Principal Investigator, Medizinische Hochschule Hannover, Hannover, Germany
Verification Date
April 2013