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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01992432
First received: November 14, 2013
Last updated: May 30, 2014
Last verified: May 2014

November 14, 2013
May 30, 2014
September 2013
July 2015   (final data collection date for primary outcome measure)
Intensity of brain activation during functional brain MRI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Prior to and after chemotherapy in older patients with breast cancer.
Same as current
Complete list of historical versions of study NCT01992432 on ClinicalTrials.gov Archive Site
  • NIH Tool box cognitive assessment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Secondary measures include the changes in cognitive assessment measured by NIH Toolbox cognitive testing prior to and after chemotherapy.
  • Structural MRI brain parameters. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    These secondary measures include gray matter density, fractional anisotropy (FA) and resting-state brain connectivity.
  • Chemotherapy toxicity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Breast Cancer
Not Provided
Single-group study: chemotherapy
Single-group study: chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Female
65 Years and older
No
Contact: Bihong T. Chen, MD., Ph.D 626 301 8396 bechen@coh.org
Contact: Arti Hurria, MD 626 256 4673 ahurria@coh.org
United States
 
NCT01992432
13278, 1R03AG045090
Yes
City of Hope Medical Center
City of Hope Medical Center
National Institute on Aging (NIA)
Principal Investigator: Bihong T. Chen, MD., Ph.D City of Hope Medical Center
City of Hope Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP