Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00369018
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2006-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}, {'id': 'C419924', 'term': '5-aminolevulinic acid hexyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-26', 'studyFirstSubmitDate': '2006-08-28', 'studyFirstSubmitQcDate': '2006-08-28', 'lastUpdatePostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lesion eradication', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Eradication of lesion and HPV', 'timeFrame': '6 and 12 months'}, {'measure': 'Safety assessment', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['photodynamic therapy', 'methyl aminolevulinate', 'hexaminolevulinate', 'dose-finding', 'cervical dysplasia'], 'conditions': ['Cervical Dysplasia']}, 'descriptionModule': {'briefSummary': 'The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).', 'detailedDescription': 'Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.\n\nThis study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive histology of CIN 1-3\n\nExclusion Criteria:\n\n* Patients with endocervical lesions\n* Patients with AGUS\n* Patients with invasive disease\n* Patients with porphyria\n* Patients sensitive to MAL and HAL'}, 'identificationModule': {'nctId': 'NCT00369018', 'briefTitle': 'A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Photocure'}, 'officialTitle': 'Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study', 'orgStudyIdInfo': {'id': 'PC CE101/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MAL 3', 'interventionNames': ['Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAL 12', 'interventionNames': ['Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAL 10, 3', 'interventionNames': ['Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAL 10, 12', 'interventionNames': ['Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAL 40, 3', 'interventionNames': ['Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HAL 40, 12', 'interventionNames': ['Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)']}], 'interventions': [{'name': 'methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)', 'type': 'DRUG', 'description': 'MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application', 'armGroupLabels': ['HAL 10, 12', 'HAL 10, 3', 'HAL 40, 12', 'HAL 40, 3', 'MAL 12', 'MAL 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevål University Hospital, Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Peter Hillemanns, Md PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Photocure', 'class': 'INDUSTRY'}}}}