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

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT01045044
• Lead Sponsor: Kettering Health Network

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.

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Medical Oncology Hematology Associates, Inc; 🇺🇸 Dayton, Ohio, United States

Innovation Center, Kettering Health Network; 🇺🇸 Kettering, Ohio, United States