Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:17 AM
Study NCT ID:
NCT05483712
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2022-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'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': 'This is a single-site study designed to generate data quantifying the skin dose under brass mesh bolus.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Dose Enhancement Under Brass Mesh Bolus', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'During days one, two, and three of radiation therapy, patients on this study utilize no-bolus, 5-mm thick Superflab bolus, and brass mesh bolus, respectively. Each day, nine in-vivo dosimeters (OSLDs) will be placed on patient skin to sample the skin dose in cGy. As a result, for each patient on this study, skin dose enhancement of brass mesh compared with no-bolus can be related to that of Superflab bolus. At the end of the study, the average and range of skin dose enhancement under brass mesh bolus for a sample size of twenty patients will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Radiation Therapy', 'Brass Mesh', 'Bolus', 'Skin Dose'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.', 'detailedDescription': "Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.\n\nComparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.\n\nPrimary outcome\n\n1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).\n2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen undergoing rotational chest wall radiotherapy following mastectomy for breast cancer treatment who would utilize Superflab bolus on some, but not all, days of radiotherapy treatment.\n\nExclusion Criteria:\n\nPatients who require daily bolus due to skin involvement or other high-risk features requiring a high skin dose will not be included.'}, 'identificationModule': {'nctId': 'NCT05483712', 'briefTitle': 'Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Cancer Centre'}, 'officialTitle': 'A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus', 'orgStudyIdInfo': {'id': '12341234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-Mastectomy Radiation Therapy Patients', 'description': 'Any patient who is going through radiation to their chest wall following mastectomy using a rotational delivery technique and 6 MV, and uses Superflab bolus for some but not all fractions of radiotherapy', 'interventionNames': ['Device: Brass Mesh Bolus']}], 'interventions': [{'name': 'Brass Mesh Bolus', 'type': 'DEVICE', 'description': 'During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.', 'armGroupLabels': ['Post-Mastectomy Radiation Therapy Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Hannah Dahn, MD', 'role': 'CONTACT', 'email': 'Hannah.dahn@nshealth.ca', 'phone': '902 473-6185'}], 'facility': 'Nova Scotia Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Hannah Dahn, MD', 'role': 'CONTACT', 'email': 'Hannah.dahn@nshealth.ca', 'phone': '902-473-6185'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Cancer Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hannah Dahn', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Physicist', 'investigatorFullName': 'Thalat Monajemi', 'investigatorAffiliation': 'Nova Scotia Cancer Centre'}}}}