Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-28 @ 9:19 PM
Study NCT ID:
NCT05698706
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2023-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-05-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure rate', 'timeFrame': '3 months', 'description': 'Frequency of complete clearance of BCC after HIFU treatment. Binary output: yes/no'}, {'measure': 'Severity of short term adverse events', 'timeFrame': '3 months', 'description': 'Safety profile after treatment of basal cell carcinoma measured on a 4-point severity score ranging from No side effects (score 0) to Severe side effects (score 3)'}], 'secondaryOutcomes': [{'measure': 'Severity of adverse events', 'timeFrame': '12 months', 'description': 'Any objective adverse effect or event, local or systemic, related to the treatment and the investigational device (wound and course of wound healing, scar formation, instrumental hazards) measured at 6, 9 and 12 months. Measured on a 4-point severity score ranging from No side effects (score 0) to Severe side effects (score 3)'}, {'measure': 'Cure rate', 'timeFrame': '12 months', 'description': 'Frequency of complete clearance of BCC after HIFU treatment measured at 6, 9, 12 months after HIFU treatment. Binary output: yes/no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin cancer', 'HIFU', 'BCC', 'Dermatology', 'High Intensity Focused Ultrasound', 'Dermoscopy'], 'conditions': ['Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '30620418', 'type': 'BACKGROUND', 'citation': 'Bove T, Zawada T, Serup J, Jessen A, Poli M. High-frequency (20-MHz) high-intensity focused ultrasound (HIFU) system for dermal intervention: Preclinical evaluation in skin equivalents. Skin Res Technol. 2019 Mar;25(2):217-228. doi: 10.1111/srt.12661. Epub 2019 Jan 8.'}, {'pmid': '31541524', 'type': 'BACKGROUND', 'citation': 'Soegaard S, Aarup V, Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound system for dermal intervention: A 12-week local tolerance study in minipigs. Skin Res Technol. 2020 Mar;26(2):241-254. doi: 10.1111/srt.12786. Epub 2019 Sep 20.'}, {'pmid': '32557832', 'type': 'BACKGROUND', 'citation': 'Serup J, Bove T, Zawada T, Jessen A, Poli M. High-frequency (20 MHz) high-intensity focused ultrasound: New Treatment of actinic keratosis, basal cell carcinoma, and Kaposi sarcoma. An open-label exploratory study. Skin Res Technol. 2020 Nov;26(6):824-831. doi: 10.1111/srt.12883. Epub 2020 Jun 17.'}, {'pmid': '34921489', 'type': 'BACKGROUND', 'citation': 'Calik J, Zawada T, Bove T. Treatment of superficial benign vascular tumors by high intensity focused ultrasound: Observations in two illustrative cases. J Cosmet Dermatol. 2022 Aug;21(8):3371-3379. doi: 10.1111/jocd.14682. Epub 2021 Dec 17.'}, {'pmid': '35125879', 'type': 'BACKGROUND', 'citation': 'Calik J, Migdal M, Zawada T, Bove T. Treatment of Seborrheic Keratosis by High Frequency Focused Ultrasound - An Early Experience with 11 Consecutive Cases. Clin Cosmet Investig Dermatol. 2022 Jan 28;15:145-156. doi: 10.2147/CCID.S348106. eCollection 2022.'}], 'seeAlsoLinks': [{'url': 'https://oldtownclinic.pl/en/', 'label': 'Website of Old Town Clinic'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma (BCC) using a new modality based on high-intensity focused ultrasound (HIFU). BCC is the most common type of skin cancer in Europe, Australia and the US. It accounts for more than 75% of all skin cancer cases in those regions. There are currently more the 14000 BCC cases registrations in Poland every year, and occurrences on a global scale are counted in several millions per year. Given the trend of aging population those numbers will only increase with time. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the study is a system capable of making controlled and targeted thermo-mechanical treatment of small intradermal volumes containing e.g. BCC cells, but without inflicting damage to the surrounding tissue.\n\nThe investigation involves an evaluation of the safety and efficacy profile 3 months after a single few-minute treatment. Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age.\n* Subjects who have received oral and written study information, accepted participation and signed the informed consent document.\n* Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions.\n* Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications.\n* Subjects, who have histologically and clinically verified basal cell carcinoma cancer of thickness not more 2.0 mm measured by ultrasound imaging or histopathological examination.\n\nExclusion Criteria:\n\n* Subjects who are less than 18 years at the time of informed consent.\n* Subject is pregnant or lactating at time of first treatment\n* Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure.\n* Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons\n* Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer.\n* Any condition predisposing to treatment-related adverse effects or complications from the ultrasound treatment.\n* Subjects with abnormal scar formation\n* Subjects with impaired wound healing\n* Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study\n* Subjects undergoing immunosuppressive treatment"}, 'identificationModule': {'nctId': 'NCT05698706', 'acronym': 'HIFU-BCC', 'briefTitle': 'High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Old Town Clinic, Poland'}, 'officialTitle': 'High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety', 'orgStudyIdInfo': {'id': 'HIFU-BCC-2023-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'De-novo BCC with thickness not more than 2.0 mm', 'description': 'Areas with de-novo BCC of thickness not more than 2.0 mm (as confirmed by ultrasound imaging or histopathological examination) will be treated by high intensity focused ultrasound', 'interventionNames': ['Device: TOOsonix System ONE-M']}], 'interventions': [{'name': 'TOOsonix System ONE-M', 'type': 'DEVICE', 'description': 'Selected BCC sites will be treated using high intensity focused ultrasound', 'armGroupLabels': ['De-novo BCC with thickness not more than 2.0 mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-127', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jacek Calik, MD, PhD', 'role': 'CONTACT', 'email': 'jacek.calik@oldtownclinic.pl', 'phone': '+48 516 222 516'}], 'facility': 'Old Town Clinic', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Jacek Calik, MD, PhD', 'role': 'CONTACT', 'email': 'jacek.calik@oldtownclinic.pl', 'phone': '+48 516 222 516'}, {'name': 'Bartosz Wozniak, MD', 'role': 'CONTACT', 'phone': '+48 516 222 516'}], 'overallOfficials': [{'name': 'Jacek Calik, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Old Town Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacek Calik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Managing Director', 'investigatorFullName': 'Jacek Calik', 'investigatorAffiliation': 'Old Town Clinic, Poland'}}}}