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


N/A
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Jason Parker, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kettering Health Network

Authority:

United States: Institutional Review Board

Study ID:

KHNIC-P09-004

NCT ID:

NCT01045044

Start Date:

December 2009

Completion Date:

October 2011

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Magnetic Resonance Imaging
  • Anthracycline based systemic chemotherapy
  • Tumor response
  • Cognitive Impairment
  • Chemo Brain
  • Breast Neoplasms
  • Cognition Disorders

Name

Location

Medical Oncology Hematology Associates, IncDayton, Ohio  45408
Innovation Center, Kettering Health NetworkKettering, Ohio  45429