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

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ClinicalTrials.gov Identifier: NCT01045044
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : January 8, 2010
Last Update Posted : April 5, 2012
Sponsor:
Information provided by:

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
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 : December 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045044


Locations
United States, Ohio
Medical Oncology Hematology Associates, Inc
Dayton, Ohio, United States, 45408
Innovation Center, Kettering Health Network
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Kettering Health Network
Investigators
Principal Investigator: Jason Parker, PhD Kettering Health Network
More Information

Responsible Party: Jason Parker, PhD, Kettering Health Network Innovation Center
ClinicalTrials.gov Identifier: NCT01045044     History of Changes
Other Study ID Numbers: KHNIC-P09-004
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

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
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders