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A Multi-modality Imaging Assessment of Chemobrain

NCT00708045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-03-15

No results posted yet for this study

Summary

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

OBJECTIVES:

To use quantitative FDG-positron emission tomography (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.

Conditions

Interventions

DRUG

[18F]fluoro-2-deoxy-D-glucose (FDG)

Brain scan with imaging tracer to assess brain tumor metabolism

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Yapp, PhD · Huntsman Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-09
Primary Completion
2015-02-05
Completion
2015-02-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00708045 on ClinicalTrials.gov