Clinical trial · Interventional
Lymphedema Progression Screening Using MRI
Imaging Noninvasively With Functional-MRI for Onset, Response and Management of Lymphatic Impairment
NCT02611557CI-TRIAL-00040221INFORMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manual lymphatic drainage therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Manual lymphatic drainage therapy
- description
- 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.
- interventionNames
- Procedure: Manual lymphatic drainage therapy
Primary outcomes (1)
- measure
- Lymphedema progression
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * Contraindication to MRI * Bilateral axillary lymph node removal * Primary lymphedema. Individuals on tyrosine kinase inhibitors or calcium channel blockers
References
Publications (5)
- RESULTDonahue 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 25752499
- RESULTRane 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 23864103
- RESULTDonahue 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 28323572
- RESULTCrescenzi 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 28245075
- DERIVEDCrescenzi 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 34687412