NCT01045044

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

January 6, 2010

Last Update Submit

April 4, 2012

Conditions

Breast Cancer

Keywords

Breast cancerMagnetic Resonance ImagingAnthracycline based systemic chemotherapyTumor responseCognitive ImpairmentChemo Brain

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Oncology Hematology Associates, Inc

Dayton, Ohio, 45408, United States

Location

Innovation Center, Kettering Health Network

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jason Parker, PhD

    Kettering Health Network

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 8, 2010

Study Start

December 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations

US(2)