Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer, chemotherapy

Up to 15 women with breast cancer who are to undergo systemic anthracycline based chemotherapy.

No interventions assigned to this group

Normal control

Up to 15 normal, healthy women.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes