A Multi-modality Imaging Assessment of Chemobrain
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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 |
- 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: | 24 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 between the age of 18 and 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 Institute orHospital. 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 Huntsman Cancer Institute or Hospital. The non-patient cohort will be age-matched woman who have not undergone any type of chemotherapy. There 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 (described below). All subjects will be age-matched as close as possible to eliminate age related cognitive effects.
Contacts and Locations| Contact: Diane Gleason, RN | 801-587-4746 | diane.gleason@hci.utah.edu |
| Contact: Britney Beardmore | 801-587-4798 | britney.beardmore@hci.utah.edu |
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| 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: | April 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Breast Cancer |
ClinicalTrials.gov processed this record on May 19, 2013