Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
1	Hexaminolevulinate (HAL)	HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
2	Placebo	Placebo suppository (single administration), laser illumination (50J/cm2)
4	Hexaminolevulinate (HAL)	HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)
5	Placebo	Placebo ointment (single administration), no illumination

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	6 month	Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.

Secondary Outcome Measures

Name	Time	Method
Eradication of HPV	6 months	High risk HPV
Incidence of Patients With Adverse Events	3 months

Locations (5): Fritzøe klinikk
🇳🇴
Larvik, Norway
Department of Obstetrics and Gynaecology, Ullevål University Hospital
🇳🇴
Oslo, Norway
Department of Obstetrics and Gyneacology, Lille University Hospital
🇫🇷
Lille, France
Department of Obstetrics and Gynecology
🇩🇪
Hannover, Germany
Medicus
🇳🇴
Trondheim, Norway