- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992432
Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC) (Brain fMRI-BC)
April 4, 2024 updated by: City of Hope Medical Center
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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South Pasadena, California, United States, 91030
- South Pasadena Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Using a prospective longitudinal study design, 25 patients will be recruited for this study from the outpatient medical oncology practice at City of Hope Medical Center.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Single-group study: chemotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of brain activation during functional brain MRI.
Time Frame: 2 years
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Prior to and after chemotherapy in older patients with breast cancer.
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2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NIH Tool box cognitive assessment.
Time Frame: 2 years
|
Secondary measures include the changes in cognitive assessment measured by NIH Toolbox cognitive testing prior to and after chemotherapy.
|
2 years
|
Structural MRI brain parameters.
Time Frame: 2 years
|
These secondary measures include gray matter density, fractional anisotropy (FA) and resting-state brain connectivity.
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2 years
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Chemotherapy toxicity.
Time Frame: 2 years
|
Chemotherapy toxicity as a secondary outcome measure will be captured in a standardized manner using the NCI Common Toxicity Criteria for Adverse Events (v4.0) (NCI CT CAE version 4.0).
Furthermore, we will determine the association of the brain MRI parameters for both structure and function with chemotherapy toxicity in older patients with breast cancer.
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bihong T. Chen, MD., Ph.D, City of Hope Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen 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.
- Chen 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.
- Chen 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.
- Chen 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2013
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 14, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimated)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13278
- 1R03AG045090 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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