Clinical trial · Observational
Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)
A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer
- 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 use advanced MRI techniques to characterize the changes that occur to the structure and functionality of the brain in older breast cancer patients receiving adjuvant chemotherapy, and determine the relationship between the brain changes and severity of chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging markers of aging, breast cancer and chemotherapy treatment, and will contribute to our understanding of the underlying pathophysiology of cognitive changes and chemotherapy toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the foundation for future, larger scale clinical studies of cognitive changes and chemotherapy toxicity in the aging cancer population.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Single-group study: chemotherapy
- description
- Single-group study: chemotherapy
Primary outcomes (1)
- measure
- Intensity of brain activation during functional brain MRI.
- timeFrame
- 2 years
- description
- Prior to and after chemotherapy in older patients with breast cancer.
Secondary outcomes (3)
- measure
- NIH Tool box cognitive assessment.
- timeFrame
- 2 years
- description
- Secondary measures include the changes in cognitive assessment measured by NIH Toolbox cognitive testing prior to and after chemotherapy.
- measure
- Structural MRI brain parameters.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) Patients with stage I-III breast cancers who are to receive adjuvant chemotherapy; * 2\) Able to understand English (the functional MRI task paradigms and neurocognitive testing are not validated in languages other than English); * 3\) Able to provide informed consent; * 4\) Patients age ≥ 65 and of any performance status. Exclusion Criteria: * 1\) Patients with metastatic disease; * 2\) Patients with MRI exclusion criteria such as claustrophobia, cardiac pacemaker, and orbital metal implants.
References
Publications (4)
- BACKGROUNDChen BT, Ghassaban K, Jin T, Patel SK, Ye N, Sun CL, Kim H, Rockne RC, Mark Haacke E, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Waisman J, Yuan Y, Somlo G, Li D, Yang R, Tan H, Katheria V, Morrison R, Hurria A. Subcortical brain iron deposition and cognitive performance in older women with breast cancer receiving adjuvant chemotherapy: A pilot MRI study. Magn Reson Imaging. 2018 Dec;54:218-224. doi: 10.1016/j.mri.2018.07.016. Epub 2018 Aug 2. PMID 30076946
- DERIVEDChen BT, Ye N, Wong CW, Patel SK, Jin T, Sun CL, Rockne RC, Kim H, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Sedrak MS, Waisman J, Yuan Y, Li D, Vazquez J, Katheria V, Dale W. Effects of chemotherapy on aging white matter microstructure: A longitudinal diffusion tensor imaging study. J Geriatr Oncol. 2020 Mar;11(2):290-296. doi: 10.1016/j.jgo.2019.09.016. Epub 2019 Nov 2. PMID 31685415
- DERIVEDChen BT, Jin T, Patel SK, Ye N, Sun CL, Ma H, Rockne RC, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Waisman J, Yuan Y, Li D, Somlo G, Vazquez J, Levi A, Tan H, Yang R, Katheria V, Hurria A. Gray matter density reduction associated with adjuvant chemotherapy in older women with breast cancer. Breast Cancer Res Treat. 2018 Nov;172(2):363-370. doi: 10.1007/s10549-018-4911-y. Epub 2018 Aug 7. PMID 30088178
- DERIVEDChen BT, Sethi SK, Jin T, Patel SK, Ye N, Sun CL, Rockne RC, Haacke EM, Root JC, Saykin AJ, Ahles TA, Holodny AI, Prakash N, Mortimer J, Waisman J, Yuan Y, Somlo G, Li D, Yang R, Tan H, Katheria V, Morrison R, Hurria A. Assessing brain volume changes in older women with breast cancer receiving adjuvant chemotherapy: a brain magnetic resonance imaging pilot study. Breast Cancer Res. 2018 May 2;20(1):38. doi: 10.1186/s13058-018-0965-3. PMID 29720224