This study monitors the incidence and progression of breast lymphedema in patients who have localized breast cancer and are undergoing radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06900023.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Cheryl Brunelle
Phone: 617-724-0127
PRIMARY OBJECTIVES:
I. To determine the natural history of BL (incidence, time course, risk factors, symptomology) through prospective screening of patients treated for BC with BCT. (Longitudinal Study)
II. PILOT Study Objective: To establish preliminary data regarding feasibility of accrual, study protocol, and regarding the sensitivity, and specificity of TDC and US to identify BL compared to the standard of clinical examination and backflow assessed through ICG lymphography (ICG lymphography imaging will only be completed at the Australian Lymphoedema Education, Research and Treatment (ALERT) site in Sydney, Australia)
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 studies.
PILOT STUDY: Patients undergo clinical exam, perometry (optoelectronic limb volumetry), bioimpedance spectroscopy (BIS), tissue dielectric constant (TDC), ultrasound (US) imaging, and digital photography, as well as complete questionnaires during 1 visit on study.
LONGITUDINAL STUDY: Patients undergo clinical exam, perometry (optoelectronic limb volumetry), BIS, TDC, US imaging, geometric camera measurements, and digital photography, as well as complete questionnaires for 24 months on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorCheryl Brunelle