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Clinical Trials/NCT01045044
NCT01045044
Withdrawn
Not Applicable

Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy

Kettering Health Network2 sites in 1 countryDecember 2009
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Kettering Health Network
Locations
2
Status
Withdrawn
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
October 2011
Last Updated
14 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (2)

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