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Completed

NCT Number: NCT01256424

Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia

An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Hannover, Hanover, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and
  • 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 days
  • 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

Treatment and study plan

HAL 5% with illumination

Drug

Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation

HAL 1% with illumination

Drug

Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation

HAL 0.2% with illumination

Drug

Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation

Placebo ointment without illumination

Drug

Treatment with a singe dose of 2g placebo ointment, no photoactivation

Primary outcomes

  1. Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.

    Time frame: 3 months after last treatment

    Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.

Secondary outcomes

  1. Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.

    Time frame: 3 months after treatment

    HPV response was defined as clearance of baseline HPV infection, asssessed by genotype

Sponsors and collaborators

Lead sponsor

Photocure

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2010
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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