Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-31 @ 9:14 PM
Study NCT ID:
NCT01482104
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2011-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lesions response rate', 'timeFrame': '3 years', 'description': 'Number of lesions in clinical complete response at follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photochemotherapy', 'methyl 5-aminolevulinate'], 'conditions': ['Skin Neoplasms', 'Carcinoma, Basal Cell']}, 'descriptionModule': {'briefSummary': 'Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.\n\nThis randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.\n\nSecondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male/female above 18 years of age\n* written informed consent\n* 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type\n\nExclusion Criteria:\n\n* pregnancy\n* breastfeeding\n* Gorlin's syndrome\n* porphyria\n* xeroderma pigmentosum\n* history of arsenic exposure\n* known allergy to MAL\n* concomitant treatment with immunosuppressive medication\n* physical or mental conditions that most likely will prevent patients attending follow-up sessions"}, 'identificationModule': {'nctId': 'NCT01482104', 'briefTitle': 'New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.', 'orgStudyIdInfo': {'id': 'EC-004'}, 'secondaryIdInfos': [{'id': '2011-004797-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAL-PDT re-treatment', 'description': '1 treatment of MAL-PDT with re-treatment of non-complete responders', 'interventionNames': ['Drug: MAL-PDT re-treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual MAL-PDT', 'description': '2 MAL-PDT treatments 1 week apart', 'interventionNames': ['Drug: usual MAL-PDT']}], 'interventions': [{'name': 'MAL-PDT re-treatment', 'type': 'DRUG', 'otherNames': ['Methyl-aminolevulinate'], 'description': 'a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months', 'armGroupLabels': ['MAL-PDT re-treatment']}, {'name': 'usual MAL-PDT', 'type': 'DRUG', 'otherNames': ['Methyl-aminolevulinate'], 'description': 'schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.', 'armGroupLabels': ['usual MAL-PDT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Dept Dermatology, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Førde', 'country': 'Norway', 'facility': 'Central Hospital Førde', 'geoPoint': {'lat': 61.45217, 'lon': 5.85717}}, {'city': 'Lillehammer', 'country': 'Norway', 'facility': 'Hudlegekontoret Lillehammer AS', 'geoPoint': {'lat': 61.11514, 'lon': 10.46628}}, {'city': 'Lørenskog', 'country': 'Norway', 'facility': 'Akerskus Dermatological Centre'}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Dept Dermatology, Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Dept Surgery, Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Hudlegen på Holtet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Stavanger', 'country': 'Norway', 'facility': 'Dept Dermato-Venereology, Stavanger University Hospital', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of Cancer Research and Molecular Medicine, NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Magne Børset, PhD prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Akershus Dermatological Centre', 'class': 'UNKNOWN'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}, {'name': 'Førde Central Hospital', 'class': 'OTHER'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Hudlegekontoret Lillehammer', 'class': 'UNKNOWN'}, {'name': 'Hudlegene på Holtet DA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}