Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
Information source: PhotoCure
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Recruiting
Sponsored by: PhotoCure Official(s) and/or principal investigator(s):
Peter Hillemanns, MD, PhD, Principal Investigator, Affiliation: Medizinische Hochschule Hannover, Hannover, Germany
Overall contact:
Gudrun Trøite, Ph.D, Phone: 47-2206-2210, Email: gt@photocure.no
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: Lesion eradication
Secondary outcome: Eradication of lesion and HPV
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
Gudrun Trøite, Ph.D, Phone: 47-2206-2210, Email: gt@photocure.no
Department of Obstetrics and Gyneacology, Lille University Hospital, Lille, France; Recruiting
Pierre Collinet, MD, PhD
Department of Obstetrics and Gynecology, Hannover, Germany; Completed
Fritzøe klinikk, Larvik, Norway; Recruiting
Tore Lunde, MD
Department of Obstetrics and Gynaecology, Ullevål University Hospital, Oslo, Norway; Completed
Medicus, Trondheim, Norway; Recruiting
Terje Sørdal
Additional Information
Starting date: January 2009
Last updated: November 26, 2010
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