Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT04292860
Status:
WITHDRAWN
Last Update Posted:
2021-05-27
First Post:
2020-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reverse Axillary Mapping in Breast Radiation Treatment Planning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}], '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': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal Investigator decided not to move forward with the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delineation of the upper extremity lymphatics (UEL) during the radiation treatment planning process using axillary reverse mapping (ARM)', 'timeFrame': 'Baseline to 1 year', 'description': 'ARM uses dye to track lymphatic flow of the upper extremities.We hypothesize that iodinated contrast injected into the upper inner arm (same site that surgeons inject during ARM) 15 minutes before the time of CT simulation will similarly be able to track the UELs. We will contour the visible iodinated dye and will measure if that anatomically correlates with the general known location of the UELs. Two radiation oncologists will independently determine if they can delineate the UELs. If both radiation oncologists can identify and contour the UELs in a reproducible fashion, we will code the patient as "UEL identified." If one or both physicians are either not able to identify the UEL on CT images or the contoured UEL structures are significantly different from each other, we will code the patient as "UEL not identified."'}], 'secondaryOutcomes': [{'measure': 'Dosimetric endpoint', 'timeFrame': 'Baseline to 1 year', 'description': 'We will measure the Dmax, Dmin, Dmean, D25%, and D75%. Dmax is the maximum dose (in units of Gray) delivered to the UEL, while Dmin is the minimum dose and Dmean is the mean dose. D25% and D75% are the minimum dose delivered to 25% and 75% of the UEL, respectively. We will also look at the percent of theoretical radiation plans that could be safely modified. This will be a binary outcome: either the plan can be modified safely, or it cannot.'}, {'measure': 'Lymphedema rate', 'timeFrame': 'Baseline to 5 years post-treatment', 'description': 'We will measure the lymphedema rates before the start of radiation and at 6 months, 12 months, 24 months, 36 months, and 60 months after the end of radiation therapy. Arm circumference will be measured 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms. An increase in arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same time-point will be considered clinically significant lymphedema.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphedema', 'Axillary Reverse Mapping', 'Breast Cancer'], 'conditions': ['Breast Cancer', 'Lymphedema']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective study is to investigate the role of axillary reverse mapping (ARM) in radiation therapy planning of patients with breast cancer. Lymphedema is a common side effect after surgery and radiation therapy for breast cancer. The use of ARM is becoming more routine in surgery to differentiate the upper extremity lymphatics (UELs) from the breast axillary drainage to preferentially spare the UELs and reduce the rates of lymphedema.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Post-operative (lumpectomy or mastectomy) female breast cancer patients who will receive radiation to the whole breast or chest wall and the regional nodes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* De novo presentation of post-operative (lumpectomy or mastectomy) female breast cancer patients to receive radiation to the whole breast or chest wall and the regional nodes. Patients who have received a sentinel lymph node (SLN) biopsy or an axillary lymph node dissection (ALND) will be eligible.\n* Greater than or equal to 18 years of age (no upper age limit).\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Prisoners.\n* Patients with metastatic breast cancer.\n* Documented allergy to iodinated contrast\n* Prior breast or axillary surgeries or radiation.'}, 'identificationModule': {'nctId': 'NCT04292860', 'briefTitle': 'Reverse Axillary Mapping in Breast Radiation Treatment Planning', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Reverse Axillary Mapping as a Lymphedema Prevention Strategy in Breast Radiation Treatment Planning', 'orgStudyIdInfo': {'id': 'LCCC1934'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Pts', 'description': 'Post-operative (lumpectomy or mastectomy) female breast cancer patients who will receive radiation to the whole breast or chest wall and the regional nodes.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dana Casey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}