Clinical trial · Interventional
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1)
NCT00708942CI-TRIAL-00010126terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study
Summary
Brief summary (as posted)
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexaminolevulinate (HAL) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
- interventionNames
- Drug: Hexaminolevulinate (HAL)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo suppository (single administration), laser illumination (50J/cm2)
- interventionNames
- Drug: Placebo
- type
- NO_INTERVENTION
- label
- 3
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.