Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-24 @ 11:07 AM
Study NCT ID:
NCT03437161
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2018-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008192', 'term': 'Deception'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean cardiac dose', 'timeFrame': 'Up to 6 weeks', 'description': 'Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.'}], 'secondaryOutcomes': [{'measure': 'Volume of heart receiving > 20 gray (Gy)', 'timeFrame': 'Up to 6 weeks', 'description': 'The volume of heart receiving \\>20Gy in DIBH plan vs. prone plan'}, {'measure': 'Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan', 'timeFrame': 'Up to 6 weeks', 'description': 'The mean LAD dose in DIBH plan vs. prone plan'}, {'measure': 'Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan', 'timeFrame': 'Up to 6 weeks', 'description': 'The maximum LAD dose in DIBH plan vs. prone plan'}, {'measure': 'Mean ipsilateral lung dose', 'timeFrame': 'Up to 6 weeks', 'description': 'The mean ipsilateral lung dose in DIBH plan vs. prone plan'}, {'measure': 'Volume of ipsilateral lung receiving > 20Gy', 'timeFrame': 'Up to 6 weeks', 'description': 'The volume of ipsilateral lung receiving \\>20Gy in DIBH plan vs. prone plan'}, {'measure': 'Volume of the contralateral breast receiving > 5 Gy', 'timeFrame': 'Up to 6 weeks', 'description': 'The volume of the contralateral breast receiving \\>5Gy in DIBH plan vs. prone plan'}, {'measure': 'Maximum point dose to planning target volume (PTV) breast', 'timeFrame': 'Up to 6 weeks', 'description': 'The maximum point dose to PTV breast in DIBH plan vs. prone plan'}, {'measure': 'Maximum separation', 'timeFrame': 'Up to 6 weeks', 'description': 'The maximum separation in DIBH plan vs. prone plan'}, {'measure': 'Distance from the mid-sternum to the nipple when the patient is in the prone position', 'timeFrame': 'Up to 6 weeks', 'description': 'Distance from the mid-sternum to the nipple when the patient is in the prone position'}, {'measure': 'PTV breast volume as calculated on the prone scan', 'timeFrame': 'Up to 6 weeks', 'description': 'PTV breast volume as calculated on the prone scan'}, {'measure': 'Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)', 'timeFrame': 'Up to 6 weeks', 'description': 'The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films'}, {'measure': 'Patient treatment plan (supine with DIBH or prone)', 'timeFrame': 'Up to 6 weeks', 'description': 'Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation', 'Prone position', 'Supine position', 'DIBH', 'Invasive Breast Carcinoma', 'Ductal Breast Carcinoma In Situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.', 'detailedDescription': "Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist\n\nExclusion Criteria:\n\n* Previous radiation to the ipsilateral breast\n* All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT03437161', 'briefTitle': 'A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation', 'orgStudyIdInfo': {'id': '16-01477'}, 'secondaryIdInfos': [{'id': 's16-01477', 'type': 'OTHER', 'domain': 'New York University School of Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation Therapy (RT)', 'description': "Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription.", 'interventionNames': ['Radiation: Radiation Therapy (RT)']}], 'interventions': [{'name': 'Radiation Therapy (RT)', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'Radiotherapy', 'RT'], 'description': 'Undergo RT either in the supine position with DIBH or in the prone position.', 'armGroupLabels': ['Radiation Therapy (RT)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Naamit Gerber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}