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

Information source: PhotoCure
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Intraepithelial Neoplasia

Intervention: Hexaminolevulinate (HAL) (Drug); Placebo (Drug); Hexaminolevulinate (HAL) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: PhotoCure

Official(s) and/or principal investigator(s):
Peter Hillemanns, MD, PhD, Principal Investigator, Affiliation: Medizinische Hochschule Hannover, Hannover, Germany

Summary

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

Clinical Details

Official title: A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Complete Response Rate

Secondary outcome:

Eradication of HPV

Incidence of Patients With Adverse Events

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Department of Obstetrics and Gyneacology, Lille University Hospital, Lille, France

Department of Obstetrics and Gynecology, Hannover, Germany

Fritzøe klinikk, Larvik, Norway

Department of Obstetrics and Gynaecology, Ullevål University Hospital, Oslo, Norway

Medicus, Trondheim, Norway

Additional Information

Starting date: January 2009
Last updated: April 17, 2013

Page last updated: August 23, 2015

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