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A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)

Phase 2
18 Years
Open (Enrolling)
Cervical Intraepithelial Neoplasia

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Trial Information

A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)

Inclusion Criteria:

- Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy)
obtained within the last month

- Satisfactory colposcopy examination including:

- visibility of entire transformation zone including the squamocolumnar junction

- visibility of entire lesion margin

- Negative endocervical os by colposcopy

- Colposcopical visible lesion at visit 2, before treatment

- Patients with an average sized uterine cervix (approximately 27mm diameter) suitable
for application of the Klemcap

- Age 18 or above

- Written informed consent signed

Exclusion Criteria:

- Previous treatment of CIN or invasive disease

- Lesion(s) extending to the vaginal vault

- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant
cells on cytology or histology or other suspicion of either micro-invasive or
invasive disease

- Suspicion of endocervical disease on colposcopy

- Current severe pelvic inflammatory disease, severe cervicitis, or other severe
gynaecological infection as per colposcopy and clinical examination

- Undiagnosed vaginal bleeding

- History of toxic shock syndrome

- Known or suspected porphyria

- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate
or aminolevulinic acid)

- Pregnancy, or intention to become pregnant during the study period

- Nursing

- Childbirth or miscarriage within six weeks of enrolment

- Use of heart pacemaker

- Participation in other clinical studies either concurrently or within the last 30

- Risk of poor protocol compliance. Patient participation should be considered with
respect to living far away from the hospital, plans for moving to another city/state,
frequent travelling, planning to become pregnant, drug abuse/alcoholic, difficult
working hours, family obligations, other illness (e.g. psychiatric), etc.

- Unwillingness to use adequate birth control (not abstinence) from screening until
last PDT

- Patient 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:


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:

To compare lesion response rates of three different doses of HAL PDT and placebo at 3 months after treatment.

Outcome Time Frame:

3 months after last treatment

Safety Issue:


Principal Investigator

Peter Hillemanns, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Hannover


United States: Food and Drug Administration

Study ID:

PC CE203/10



Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • CIN
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ