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

Breast Cancer Clinical Trial

— Brain fMRI-BC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01992432
• Other study ID #: 13278
• Secondary ID: 1R03AG045090
• Status: Active, not recruiting
• Start date: September 30, 2013
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	South Pasadena Cancer Center	South Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of brain activation during functional brain MRI.	Prior to and after chemotherapy in older patients with breast cancer.	2 years
Secondary	NIH Tool box cognitive assessment.	Secondary measures include the changes in cognitive assessment measured by NIH Toolbox cognitive testing prior to and after chemotherapy.	2 years
Secondary	Structural MRI brain parameters.	These secondary measures include gray matter density, fractional anisotropy (FA) and resting-state brain connectivity.	2 years
Secondary	Chemotherapy toxicity.	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.	2 years