Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:31 AM
Study NCT ID:
NCT07323966
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Stability of patient's position", 'timeFrame': 'Through the course of radiation therapy (up to 6 weeks)', 'description': 'The stability of the patient\'s position will be assessed:\n\n* on the basis of "internal" movements (of the skull) detected by scanner imaging before and after the simulated session (on-board CBCT)\n* on the basis of surface movements monitored by SGRT throughout the session.'}], 'secondaryOutcomes': [{'measure': "Patient's feelings with and without the mask", 'timeFrame': 'Through the course of radiation therapy (up to 6 weeks)', 'description': 'Patients are asked to fill in a questionnaire about their feelings (comfort, anxiety, claustrophobia, isolation, pain) during radiotherapy sessions with a mask and simulated sessions without an immobilization mask.'}, {'measure': 'Preference of treatment', 'timeFrame': 'Through the course of radiation therapy (up to 6 weeks)', 'description': 'Patients are asked to indicate whether they prefer to be treated with or without a mask.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiotherapy', 'brain tumor', 'mask', 'surface guidance'], 'conditions': ['Brain Tumor']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the technical feasibility of brain radiotherapy without immobilization masks using surface imaging to ensure accurate patient positioning and continuous motion monitoring.', 'detailedDescription': "In brain radiotherapy, immobilization using a thermoplastic mask is a standard practice to ensure treatment accuracy. However, this method causes discomfort and anxiety for patients. The development of surface imaging (Surface Guided Radiation Therapy, SGRT) could offer a solution to this problem. SGRT is a non-invasive and non-ionizing imaging technique that uses cameras to capture the patient's position in real-time. In mask-free treatment, the radiation beam can be interrupted when motion exceeds a certain threshold and restarts only when the position is corrected.\n\nNowadays, very few studies have examined the concept of radiation therapy without immobilization masks using SGRT.\n\nAs part of this study, participants will take part in a simulated mask-free session. We will determine the stability of the patient's position in the absence of a mask. Participants will also complete questionnaires concerning their feelings during sessions with and without masks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Brain tumor treated with fractionated radiotherapy\n* Able to read and complete a questionnaire in French\n\nExclusion Criteria:\n\n* Inability to remain still'}, 'identificationModule': {'nctId': 'NCT07323966', 'acronym': 'MASKLESS', 'briefTitle': 'Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Feasibility of Mask-Free Radiotherapy for Brain Tumor Patients', 'orgStudyIdInfo': {'id': '2025/25JUL/316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy session without mask', 'description': 'A radiotherapy session without a mask will be simulated twice (during the first week and last week of treatment) during two scheduled treatment sessions.', 'interventionNames': ['Device: Surface Guided Radiation Therapy without mask']}], 'interventions': [{'name': 'Surface Guided Radiation Therapy without mask', 'type': 'DEVICE', 'description': 'Patients are positioned using SGRT based on the reference position reconstructed from the simulation scanner. They are asked to remain still during the typical duration of a conventional radiotherapy session. Patient motion is monitored by SGRT throughout the simulated session. A CBCT scan is performed before and after the session. No treatment is delivered.', 'armGroupLabels': ['Radiotherapy session without mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Woluwe-Saint-Lambert', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Dario Di Perri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}], 'centralContacts': [{'name': 'Dario Di Perri', 'role': 'CONTACT', 'email': 'dario.diperri@saintluc.uclouvain.be', 'phone': '+32 2 764 47 52\u202c'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}