Clinical trial NCT01045044: Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy
Official title: Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Breast cancer
Magnetic Resonance Imaging
Anthracycline based systemic chemotherapy
Tumor response
Cognitive Impairment
Chemo Brain
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Medical Oncology Hematology Associates, Inc
state: Ohio
city: Kettering
country: United States
facility: Innovation Center, Kettering Health Network
state: Ohio
Study officials:
affiliation: Kettering Health Network
name: Jason Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References: