Imaging Sodium and Lymphatics in Lymphedema

NCT05242900 | Active Not Recruiting

• 3 other identifiers: 3024031R01HL155523-01202424
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema of Leg; Lymphedema, Secondary; Lymphedema Related Fibrosis

Keywords

MRI; sodium; lymphedema; adipose tissue; fibrosis

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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

• 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 Outcomes (6)

• Concentration in limb extracellular water

  Baseline and after a routine course of physical therapy (approximately 6 weeks)

• Concentration in skin water

  Baseline and after a routine course of physical therapy (approximately 6 weeks)

• Change in skin elasticity

  Baseline and after a routine course of physical therapy (approximately 6 weeks)

• Concentration of limb extracellular water at baseline

  Baseline

• Baseline skin water

  Baseline

Study Arms (3)

At-risk for lymphedema

Participants at-risk for leg lymphedema

Other: Standard imaging protocol

With lymphedema

Participants with leg lymphedema

Other: Standard imaging protocol

With lymphedema undergoing complete decongestive therapy (CDT)

Participants with leg lymphedema undergoing routine complete decongestive therapy (CDT)

Procedure: Complete decongestive therapy; Other: Standard imaging protocol

Interventions

Complete decongestive therapy PROCEDURE

The investigators will identify participants undergoing clinically-indicated interventions that they are already receiving for their routine clinical management (complete decongestive physical therapy). They will make no evaluation of the efficacy of these procedures, but rather will test fundamental hypotheses regarding lymphatic clearance of tissue sodium.

Also known as: manual lymphatic drainage, compression, exercise

With lymphedema undergoing complete decongestive therapy (CDT)

Standard imaging protocol OTHER

The standard imaging protocol entails noninvasive magnetic resonance imaging techniques including sodium and lymphatic angiography.

At-risk for lymphedema; With lymphedema; With lymphedema undergoing complete decongestive therapy (CDT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will recruit adults who are at-risk for lower-extremity lymphedema (n=30) or who have lower-extremity secondary lymphedema (n=45).

You may qualify if:

• Biologically Female
• Age range = 18-80 years
• BMI range = 18 to 40 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis; Fibrosis

Interventions

Manual Lymphatic Drainage; Exercise

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rachelle Crescenzi, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 16, 2022
• Study Start: October 10, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)