Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:12/27/2018
Start Date:September 30, 2013
End Date:June 2019
Contact:Bihong T. Chen, MD., Ph.D
Email:bechen@coh.org
Phone:626 301 8396

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A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer

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.

Breast cancer is the leading cancer diagnosed among woman in the US and is the second leading
cause of cancer deaths. Adjuvant chemotherapy has been proven to decrease the risks of
relapse and mortality from breast cancer. However, older adults are at increased risk for
chemotherapy toxicity, including an increased risk of treatment-related mortality. At
present, there is only preliminary evidence regarding which brain structures and functions
are affected by chemotherapy and toxicity in breast cancer patients. However, this prior
research did not specifically study older women. Thus, there is a need to establish a more
sensitive test that has reproducible biomarkers, to identify the older breast cancer patients
who are at higher risk for chemotherapy toxicity Our long term goal is to identify highly
sensitive and reproducible brain MRI biomarkers that are associated with chemotherapy
toxicity in aging cancer patients. Toward that goal, the objective of this study is to define
the changes that occur on brain MRI and to determine the relationship between brain MRI
changes and chemotherapy toxicity in older adults with breast cancer. We aim to 1) define
structural and functional changes that occur on brain MRI of older women with breast cancer
receiving adjuvant chemotherapy and; 2) determine the relationship between the severity of
structural and functional changes on brain MRI and chemotherapy toxicity. We expect that the
severity of structural and functional changes to the brain MRI in our patients will correlate
with the severity of chemotherapy toxicity. The proposed study is significant because it
focuses on the unknown relationship between brain MRI changes and chemotherapy toxicity in
older women with breast cancer. It is innovative because it proposes advanced MRI techniques
to study and identify the novel potential biomarkers for chemotherapy toxicity in older
adults with breast cancer. It will have a positive impact by helping to clarify the
underlying pathophysiology of cognitive decline caused by chemotherapy toxicity. The data
generated from this pilot study will also help to serve as a foundation for future large
scale studies of cognition and chemotherapy in older adults.

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.
We found this trial at
2
sites
South Pasadena, California 91030
Principal Investigator: Stephen Koehler, MD
Phone: 626-396-2900
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Duarte, California 91010
Principal Investigator: Bihong T. Chen, MD., Ph.D
Phone: 606-301-8396
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Duarte, CA
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