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
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 25
Study Start Date: September 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single-group study: chemotherapy
Single-group study: chemotherapy

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992432

Contacts
Contact: Bihong T. Chen, MD., Ph.D 626 301 8396 bechen@coh.org
Contact: Arti Hurria, MD 626 256 4673 ahurria@coh.org

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Bihong T. Chen, MD., Ph.D.    606-301-8396    bechen@coh.org   
Contact: Arti Hurria, MD    626 256 4673    ahurria@coh.org   
Principal Investigator: Bihong T. Chen, MD., Ph.D         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Bihong T. Chen, MD., Ph.D City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01992432     History of Changes
Other Study ID Numbers: 13278, 1R03AG045090
Study First Received: November 14, 2013
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
Brain magnetic resonance imaging
chemotherapy toxicity
older woman
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014