Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy
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Purpose
We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.
| Condition |
|---|
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Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy |
| Enrollment: | 0 |
| Study Start Date: | December 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Breast cancer, chemotherapy
Up to 15 women with breast cancer who are to undergo systemic anthracycline based chemotherapy.
|
|
Normal control
Up to 15 normal, healthy women.
|
Detailed Description:
In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Breast cancer cohort will be patients of Medical Oncology Hematology Associates Inc., Dayton, OH
Normal controls will be recruited from Kettering College of Medical Arts and the Kettering Health Network.
Inclusion Criteria:
- Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
- Prescribed, but not yet begun, anthracycline based systemic chemotherapy
- Not prescribed Avastin
- Able to read and write in English
- Have signed informed consent
Exclusion Criteria:
- Diagnosed psychiatric disorder
- Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
- Serious, unstable medical or mental illness
- Medical contraindication to any study procedure
- Current alcohol or other substance use disorder (excluding nicotine)
- Have not read and signed informed consent, or do not understand its contents
Contacts and Locations| United States, Ohio | |
| Medical Oncology Hematology Associates, Inc | |
| Dayton, Ohio, United States, 45408 | |
| Innovation Center, Kettering Health Network | |
| Kettering, Ohio, United States, 45429 | |
| Principal Investigator: | Jason Parker, PhD | Kettering Health Network |
More Information
No publications provided
| Responsible Party: | Jason Parker, PhD, Kettering Health Network Innovation Center |
| ClinicalTrials.gov Identifier: | NCT01045044 History of Changes |
| Other Study ID Numbers: | KHNIC-P09-004 |
| Study First Received: | January 6, 2010 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kettering Health Network:
|
Breast cancer Magnetic Resonance Imaging Anthracycline based systemic chemotherapy |
Tumor response Cognitive Impairment Chemo Brain |
Additional relevant MeSH terms:
|
Breast Neoplasms Cognition Disorders Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013