Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-24 @ 5:01 PM
Study NCT ID:
NCT03941756
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2019-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058922', 'term': 'Inflammatory Breast Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 252}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volumetric diagnosis of lymphedema', 'timeFrame': '18 months', 'description': 'If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.'}, {'measure': 'Incidence of lymphedema', 'timeFrame': '18 months', 'description': 'Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage III Breast Cancer AJCC v8', 'Breast Inflammatory Carcinoma', 'Locally Advanced Breast Carcinoma', 'Melanoma']}, 'descriptionModule': {'briefSummary': 'This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.\n\nSECONDARY OBJECTIVES:\n\nI. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.\n\nGROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.\n\nAfter completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients greater than or equal to 18 years of age.\n* Patients willing to participate.\n* Patients able to complete informed consent.\n* Patients will be eligible for inclusion if they fall into one for two groups:\n\n * Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy\n * Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.\n\nExclusion Criteria:\n\n* Patients taking anticoagulants within 7 days prior to surgery.\n* Patients that are known to be pregnant at the time of surgery.\n* Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.\n* Patients with body mass index (BMI) greater than 50.0.'}, 'identificationModule': {'nctId': 'NCT03941756', 'briefTitle': 'Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '2018-0127'}, 'secondaryIdInfos': [{'id': 'NCI-2019-02320', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0127', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (LVB)', 'description': 'Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.', 'interventionNames': ['Drug: Indocyanine Green', 'Procedure: Lymphangiography', 'Procedure: Lymphovenous Bypass']}, {'type': 'NO_INTERVENTION', 'label': 'Group II (no intervention)', 'description': 'Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.'}], 'interventions': [{'name': 'Indocyanine Green', 'type': 'DRUG', 'otherNames': ['ICG'], 'description': 'Given IV', 'armGroupLabels': ['Group I (LVB)']}, {'name': 'Lymphangiography', 'type': 'PROCEDURE', 'otherNames': ['Lymphography'], 'description': 'Undergo lymphangiography', 'armGroupLabels': ['Group I (LVB)']}, {'name': 'Lymphovenous Bypass', 'type': 'PROCEDURE', 'otherNames': ['Lymphovenous Anastomosis'], 'description': 'Undergo LVB', 'armGroupLabels': ['Group I (LVB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Schaverien', 'role': 'CONTACT', 'email': 'sehull@mdanderson.org', 'phone': '832-499-6321'}, {'name': 'Sara Hull, BSN,MHA,RN', 'role': 'CONTACT', 'email': 'sehull@mdanderson.org', 'phone': '832-499-6321'}, {'name': 'Mark Schaverien', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Mark Schaverien', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}