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

Sponsor

Kettering Health Network (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01045044

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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