Fluid Measurements and MRI in Determining Biomarkers of Lymphatic Dysfunction in Patients with Breast Cancer

Status: Active

Description

This trial uses fluid measurements of the arm and MRI to determine biomarkers of lymphatic dysfunction in patients with breast cancer. Studying the lymphatic system (the part of your body that helps to process and clear waste products) in different ways will help doctors understand more about lymphedema (excess fluid after lymph nodes are removed) and help with prevention and management of lymphedema in patients with breast cancer.

Eligibility Criteria

Inclusion Criteria

  • AIM 1: Females planning to have unilateral axillary lymph node removal surgery as a component of their cancer regime.
  • AIM 2: Females who have already had unilateral axillary lymph node removal surgery as a component of their cancer regime.
  • AIM 3: Females diagnosed with unilateral secondary lymphedema in the upper quadrant and/or extremity following cancer related surgery involving removal of any axillary lymph nodes and/or radiation therapy.

Exclusion Criteria

  • Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction.
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
  • Subjects who have cerebral aneurysm clips.
  • Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
  • Pregnant women.
  • Subjects who have open wounds on either wrist and/or right ankle because of contraindications with placement of electrodes to obtain the L-DEX U400 readings.
  • Also excluded are subjects incapable of giving informed written consent: * Subjects who are non-English speaking, children/minors, pregnant women/fetal tissue/placenta, cognitively impaired, prisoners. * Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher. * Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders. * Prisoners.
  • To minimize discomfort, we will also exclude subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet.
  • AIM 1: Any contraindication to MRI.
  • AIM 1: Any axillary lymph node removal procedure already performed before study visit.
  • AIM 1: Persons who are deemed clinically unsuitable for an MRI by their treating physician.
  • AIM 1: Severe claustrophobia.
  • AIM 1: To minimize discomfort, we will also exclude subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet. All participants will be screened with the safety screening form currently used for research studies on all research MRI scanner.
  • AIM 1: Open wounds on right ankle or bilateral wrists for purposes of obtaining external L-Dex extracellular fluid reading.
  • AIM 1: Subjects incapable of giving informed written consent: * Subjects who are non-English speaking. * Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher. * Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.
  • AIM 1: Prisoners.
  • AIM 2: Any contraindication to MRI.
  • AIM 2: Persons with a bilateral risk for arm and/or upper quadrant lymphedema.
  • AIM 2: Persons with signs or symptoms of lymphedema before their first MRI study visit.
  • AIM 2: Persons who are deemed clinically unsuitable for an MRI by their treating physician.
  • AIM 2: Severe claustrophobia.
  • AIM 2: Minors (younger than 18 years).
  • AIM 2: To minimize discomfort, we will also exclude subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet. All participants will be screened with the safety screening form currently used for research studies on all research MRI scanners.
  • AIM 2: Open wounds on right ankle or bilateral wrists for purposes of obtaining external L-Dex extracellular fluid reading.
  • AIM 2: Also excluded are subjects incapable of giving informed written consent: * Subjects who are non-English speaking. * Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher. * Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.
  • AIM 2: Prisoners.
  • AIM 3: Any contraindication to MRI.
  • AIM 3: Persons who have undergone bilateral axillary lymph node removal and thus are at risk for bilateral secondary lymphedema.
  • AIM 3: Persons who are deemed clinically unsuitable for an MRI or lymphedema therapy by their treating physician.
  • AIM 3: Severe claustrophobia.
  • AIM 3: Minors (younger than 18 years).
  • AIM 3: To minimize discomfort, we will also exclude subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet. All participants will be screened with the safety screening form currently used for research studies on all research MRI scanners and the manual lymphatic drainage screening form administered by a licensed lymphedema physical therapist.
  • AIM 3: Open wounds on right ankle or bilateral wrists for purposes of obtaining external L-Dex extracellular fluid reading.
  • AIM 3: Also excluded are subjects incapable of giving informed written consent: * Subjects who are non-English speaking. * Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher. * Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders.
  • AIM 3: Prisoners.

Locations & Contacts

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Manus Donahue
Phone: 615-322-8350
Email: m.donahue@vumc.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare in vivo anatomical and novel molecular imaging contrasts between lymph nodes (LNs) with versus without biopsy-confirmed metastasis. (Aim 1)

II. To identify sub-clinical biomarkers of lymphatic insufficiency using quantitative evaluation of lymphatic vessel anatomy, axillary edema, and interstitial adiposity. (Aim 2)

III. To evaluate the impact of complex decongestive therapy (CDT) with and without graded negative pressure therapy on internal measures of lymphatic dysfunction and edema in patients with chronic breast cancer treatment-related lymphedema (BCRL). (Aim 3)

OUTLINE:

AIM I: Patients undergo external measurements obtaining weight, height, arm volumetric measurements (Perometer) and extracellular fluid levels in the arms (L-Dex and MoistureMeterD) and upper body (MoistureMeterD) followed by non-invasive magnetic resonance imaging (MRI) over 1 hour to evaluate lymph fluid properties in the upper extremities.

AIM II: Patients undergo monitoring of lymphatic system and arm changes over 30 minutes every 6 months for 2 years using non-MRI measurements. Patients that develop lymphedema may undergo a second MRI scan.

AIM III: Patients undergo non-MRI and MRI measurements as in AIM I at visits 1, 11, 12, and 22. Patients then receive complex decongestive therapy (CDT) alone over 75 minutes twice per week for 3 weeks and then once per week for 3-5 weeks for 9 visits and then CDT with graded negative pressure over 75 minutes twice per week for 3 weeks and then once per week for 3-5 weeks for 9 visits.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Screening

Lead Organization

Lead Organization
Vanderbilt University / Ingram Cancer Center

Principal Investigator
Manus Donahue

Trial IDs

Primary ID VICC BRE 18156
Secondary IDs NCI-2018-03754
Clinicaltrials.gov ID NCT03760744