Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System
The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT.
Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Feasibility Study for Imaging of Peripheral Tumors With a High-Resolution PET Imaging System|
- Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images. [ Time Frame: 20 minutes for imaging using PEMFlex Solo II ] [ Designated as safety issue: No ]Study considered a success if 70% of lesions identified using standard images are also identifiable in the PEM image.
|Study Start Date:||December 2009|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: PEM Scan
HR PEM images (High Resolution PEMFlex Solo II scan images)
Procedure: HR PEM Scan
PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of body that has, or is suspected to have cancer following routine, standard, positron emission tomography/computed tomography (PET/CT) scan
If you agree to take part in this study, right after your already-scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.
You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of the area being checked for cancer. It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.
Length of Study:
After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.
This is an investigational study. The PEMFlex Solo II is commercially available and designed for PET scan imaging of the breast. The use of the PEMFlex Solo II for imaging other parts of the body is investigational.
Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008930
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77070|
|Study Chair:||Eric Rohren, MD||UT MD Anderson Cancer Center|