Lymphedema Progression Screening Using MRI
INFORM
Imaging Noninvasively With Functional-MRI for Onset, Response and Management of Lymphatic Impairment
1 other identifier
interventional
90
1 country
2
Brief Summary
This study will apply novel, noninvasive structural and functional magnetic resonance imaging (MRI) methods to patients with mild and moderate breast cancer-related lymphedema (BCRL) for the first time to test fundamental hypotheses about relationships between lymphatic compromise and imaging biomarkers that may portend disease progression and individualized therapy response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 26, 2019
August 1, 2019
4.3 years
November 18, 2015
August 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lymphedema progression
Progression to more advanced stage of lymphedema. Stage 0 to Stage 1 criteria: ≥ 2 cm difference in arm circumference between involved and uninvolved arms. Fibrosis: none or minimal; Pitting: pits on pressure; Elevation: reduces edema; Skin: no change. Stage I to II progression criteria: Stage I circumference criteria with Fibrosis: moderate; Pitting: may be present; Elevation: does not fully reduce edema (minimal to no reduction); Skin: no change. All progression will be determined using the Perometer by a certified lymphedema therapist.
2 years
Study Arms (1)
Manual lymphatic drainage therapy
OTHERPatients will undergo a 50 min manual lymphatic drainage (MLD) therapy session by a certified lymphedema therapist. MLD therapy is performed routinely for standard of care in these patients and consists of light massage to facilitate lymphatic fluid mobility.
Interventions
Patients will undergo a 50 min manual lymphatic drainage (MLD) therapy session by a certified lymphedema therapist. MLD therapy is performed routinely for standard of care in these patients and consists of light massage to facilitate lymphatic fluid mobility.
Eligibility Criteria
You may qualify if:
- sex=female
- age=40-70 yrs
- clinical diagnosis of lymphedema secondary to breast cancer treatment (including node dissection, radiation therapy, and/or sentinel node biopsy).
You may not qualify if:
- Contraindication to MRI
- Bilateral axillary lymph node removal
- Primary lymphedema. Individuals on tyrosine kinase inhibitors or calcium channel blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Related Publications (5)
Donahue MJ, Donahue PC, Rane S, Thompson CR, Strother MK, Scott AO, Smith SA. Assessment of lymphatic impairment and interstitial protein accumulation in patients with breast cancer treatment-related lymphedema using CEST MRI. Magn Reson Med. 2016 Jan;75(1):345-55. doi: 10.1002/mrm.25649. Epub 2015 Mar 7.
PMID: 25752499RESULTRane S, Donahue PM, Towse T, Ridner S, Chappell M, Jordi J, Gore J, Donahue MJ. Clinical feasibility of noninvasive visualization of lymphatic flow with principles of spin labeling MR imaging: implications for lymphedema assessment. Radiology. 2013 Dec;269(3):893-902. doi: 10.1148/radiol.13120145. Epub 2013 Oct 28.
PMID: 23864103RESULTDonahue PM, Crescenzi R, Scott AO, Braxton V, Desai A, Smith SA, Jordi J, Meszoely IM, Grau AM, Kauffmann RM, Sweeting RS, Spotanski K, Ridner SH, Donahue MJ. Bilateral Changes in Deep Tissue Environment After Manual Lymphatic Drainage in Patients with Breast Cancer Treatment-Related Lymphedema. Lymphat Res Biol. 2017 Mar;15(1):45-56. doi: 10.1089/lrb.2016.0020.
PMID: 28323572RESULTCrescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.
PMID: 28245075RESULTCrescenzi R, Donahue PMC, Garza M, Lee CA, Patel NJ, Gonzalez V, Jones RS, Donahue MJ. Elevated magnetic resonance imaging measures of adipose tissue deposition in women with breast cancer treatment-related lymphedema. Breast Cancer Res Treat. 2022 Jan;191(1):115-124. doi: 10.1007/s10549-021-06419-w. Epub 2021 Oct 23.
PMID: 34687412DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manus J Donahue, PhD
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Radiology
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 23, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
August 26, 2019
Record last verified: 2019-08