Lymphedema of Leg Clinical Trial
Official title:
Imaging Sodium and Lymphatics in Lymphedema
Recent evidence supports lymphatic regulation of tissue sodium handling, however fundamental gaps persist in knowledge regarding the role of lymphatics in human diseases of sodium dysregulation. The goal of this work is to apply novel, noninvasive imaging tools to measure relationships between lymphatic function and tissue sodium in patients with well-characterized lymphedema. Findings are intended to inform mechanisms of lymphatic clearance of tissue sodium, and provide novel imaging biomarkers of lymphedema progression and treatment response.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Biologically Female - Age range = 18-80 years - BMI range = 18 to 40 kg/m2 Exclusion Criteria: - Primary lymphedema - Contraindication to 3T MRI - Pregnant - Severe claustrophobia - Inability to provide written, informed consent - Active infection anywhere in the body, or open wound on the lower-extremities or at locations for measurement - Subjects who cannot adhere to the experimental protocols for any reason |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of tissue sodium content | Research participants will undergo periodic noninvasive sodium MRI after clinically-indicated complete decongestive therapy. The study team will measure change in tissue sodium content (mmol/L) in the treated extremities to study effects of lymphatic stimulation on sodium clearance. | Baseline to completion of routine course of physical therapy (approximately 6 weeks) | |
Primary | Number of participants that changed lymphedema severity | Research participants will undergo periodic noninvasive magnetic resonance lymphangiography after clinically-indicated complete decongestive therapy. The study team will measure change in quantified lymphatic stasis in the treated extremities to study effects of lymphatic stimulation on lymphedema severity. | Baseline to completion of routine course of physical therapy (approximately 6 weeks) | |
Primary | Concentration of tissue sodium content baseline | For participants at-risk or with lymphedema, noninvasive sodium MRI will measure tissue sodium content (mmol/L) in the extremities to study sodium in lymphedema. | Baseline | |
Primary | Quantification of lymphatic states in extremities at baseline | For participants at-risk or with lymphedema, noninvasive MR lymphangiography will measure quantified lymphatic stasis in the extremities to study lymphatic physiology in lymphedema. | Baseline | |
Secondary | Concentration in limb extracellular water | Research participants will undergo periodic assessment by bioimpedance spectroscopy to estimate limb extracellular water (whole-limb resistance, Ohms) after clinically-indicated complete decongestive therapy. The study team will measure change in limb extracellular water (whole-limb resistance, Ohms) in the treated extremities to study effects of lymphatic stimulation on tissue composition. | Baseline and after a routine course of physical therapy (approximately 6 weeks) | |
Secondary | Concentration in skin water | Research participants will undergo periodic assessment by tissue dielectric probe to estimate skin water (% water) after clinically-indicated complete decongestive therapy. The study team will measure change in skin water (% water) in the treated extremities to study effects of lymphatic stimulation on tissue composition. | Baseline and after a routine course of physical therapy (approximately 6 weeks) | |
Secondary | Change in skin elasticity | Research participants will undergo periodic assessment by fibrometer probe to estimate skin elasticity (Newtons of induration) after clinically-indicated complete decongestive therapy. The study team will measure change in skin elasticity (Newtons of induration) in the treated extremities to study effects of lymphatic stimulation on tissue composition. | Baseline and after a routine course of physical therapy (approximately 6 weeks) | |
Secondary | Concentration of limb extracellular water at baseline | For participants at-risk or with lymphedema, baseline limb extracellular water (whole-limb resistance, Ohms) will be estimated in the extremities to study tissue composition in lymphedema. | Baseline | |
Secondary | Baseline skin water | For participants at-risk or with lymphedema, baseline skin water (% water) will be estimated in the extremities to study tissue composition in lymphedema. | Baseline | |
Secondary | Baseline skin elasticity | For participants at-risk or with lymphedema, baseline skin elasticity (Newtons of induration) will be estimated in the extremities to study tissue composition in lymphedema. | Baseline |
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