Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(No participants enrolled)
Sponsor:
Information provided by:
Kettering Health Network
ClinicalTrials.gov Identifier:
NCT01045044
First received: January 6, 2010
Last updated: April 4, 2012
Last verified: April 2012

January 6, 2010
April 4, 2012
December 2009
October 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01045044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy
Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Breast Cancer
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01045044
KHNIC-P09-004
No
Jason Parker, PhD, Kettering Health Network Innovation Center
Kettering Health Network
Not Provided
Principal Investigator: Jason Parker, PhD Kettering Health Network
Kettering Health Network
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP