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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01045044
• Other study ID #: KHNIC-P09-004
• Status: Withdrawn
• Phase: N/A
• First received: January 6, 2010
• Last updated: April 4, 2012
• Start date: December 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognition Disorders

Locations

Country	Name	City	State
United States	Medical Oncology Hematology Associates, Inc	Dayton	Ohio
United States	Innovation Center, Kettering Health Network	Kettering	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kettering Health Network

Country where clinical trial is conducted

United States,