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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Breast
N/A
Adults
Not Available
Not Available
Donahue, Manus
Local
Vanderbilt University
11-20-2018
Diagnostic
VICCBRE18156
NCT03760744

Eligibility

18 Years
BOTH
NO
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.

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