Clinical Trial: Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment
Brief Summary:
The initial goal of the investigators interdisciplinary group of imagers, oncologists, neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot study.
The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy.2,3 To date there have been few studies examining this problem using multi-modality imaging techniques to better understand this complex and significant problem.
FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive dysfunction in older populations complaining of memory dysfunction. It is well recognized that FDG-PET can assist with the differentiation and characterization of various cognitive disorders due to unique patterns of cerebral metabolism caused by various cognitive and dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and has a high reliability in detecting Alzheimers disease (AD) many years before it can be diagnosed reliably using clinical criteria.4
To the investigators knowledge, there has been only a single small study using FDG-PET and bolus water activation paradigms in cancer patients complaining of memory problems.7 To date, there have been no studies using Flutemetamol as a PET imaging agent to assess the possibility of increased amyloid plaque burden as a potential contributing factor to the cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of this project is in the combined use of Flutemetamol-PET, FDG-PET,
Detailed Summary:
Sponsor: University of Utah
Current Primary Outcome: [18F]Flutemetamol and [18F]fluoro-2-deoxy-D-glucose (FDG) PET imaging agents and MRI in breast cancer patients with Chemotherapy-Induced Cognitive Impairment (CICI) to check brain changes. [ Time Frame: patients with CICI will have 2 scans within approximately 3 days. Medical record review will continue for approximately 2 years following the last scan to review patient progress. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Utah
Dates:
Date Received: December 11, 2014
Date Started: December 2015
Date Completion: January 2019
Last Updated: December 12, 2016
Last Verified: December 2016