A Multi-modality Imaging Assessment of Chemobrain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00708045
First received: June 27, 2008
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be eligible for this trial.

OBJECTIVES:

To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005]. The study is exploratory to obtain proof of feasibility pilot data to support an eventual submission to the NIH.

Neuropsychological Testing A battery of testing will be used to assess the subjective complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same battery of tests will be used to assure that the non-symptomatic patient control group and the age-matched normal controls do not exhibit any cognitive impairment. The following set of clinical tests will be performed to assess the degree of cognitive impairment in all subjects.


Condition Intervention
Cancer
Procedure: Imaging assessments

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multi-modality Imaging Assessment of Chemobrain

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy


Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
Procedure: Imaging assessments
FDG-PET scans, functional MRI (fMRI) scans, Neuropsychological Testing
Other Names:
  • FDG-PET scans
  • functional MRI (fMRI)scans
  • Neuropschological Testing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria: Pre-screening will be conducted to ensure that all subjects are in good neurologic health with no history of seizures or other neurological disorders, and that they have no ferromagnetic implants or clips in their body. Subjects will be right-handed exclusive-English speakers with normal hearing.

Exclusion criteria: If a subject is found to have profound or severe depression after the Neuropsychological and Cognitive Testing session they may be excluded from the imaging portion of the study. This is justified as the imaging session would not be valid as the biologic correlates of depression rather than chemobrain would be imaged. Subjects found to have profound or severe depression will be notified and appropriate referral made to get them the necessary medical care to treat their depression.

Three cohorts of 8 women each under the age of 65 will be recruited for this exploratory pilot study. The "affected patient cohort" will be woman with complaints of cognitive or memory dysfunction who have received adjuvant chemotherapy for the treatment of breast cancer. These patients will be those being treated at Huntsman Cancer Hospital and be the patients of Dr Saundra Buys or Dr John Ward. The second "patient control cohort" will be age-matched woman with breast cancer who have undergone similar adjuvant chemotherapy for the same amount of time who have no complaints of memory dysfunction. Again these are primarily patients of Drs. Buys or Ward. The non-patient cohort will be age-matched woman who have not undergone any type of chemotherapy. These individuals will be recruited from friends of female family members of the two breast cancer cohorts. All individuals will be assessed for dementia and cognitive impairment using the same battery of dementia and cognitive/neuropsychological testing. All subjects will be age-matched as close as possible to eliminate age related cognitive effects. Subjects will be right-handed exclusive-English speakers with normal hearing. Pre-screening will be conducted to ensure that all subjects are in good neurologic health with no history of seizures or other neurological disorders, and that they have no ferromagnetic implants or clips in their body.

Up to 40 subjects may be enrolled to ensure 24 evaluable subjects.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708045

Contacts
Contact: Kelli Rasmussen 801-213-4218 kelli.rasmussen@hci.utah.edu
Contact: Britney Beardmore 801-587-4798 britney.beardmore@hci.utah.edu

Locations
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: John M Hoffman, MD Huntsman Cancer Institute
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00708045     History of Changes
Other Study ID Numbers: HCI21946
Study First Received: June 27, 2008
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Breast Cancer

ClinicalTrials.gov processed this record on September 22, 2014