MRI FDG PET Imaging Cervix
The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.
The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:
- special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
- an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Prospective Study of the Utility of Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted MRI (DWI)and Positron Emission Tomography (PET) Imaging With 18F-Fluorodeoxyglucose (18FDG) in Brachytherapy for Cervix Cancer|
- Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]This objective will evaluate the potential for translation of this technique to centres with limited MRI access.
- Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Imaging techniques for visualizing the brachytherapy applicator. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
|Experimental: 18-FDG PET/CT, DWI, DCE-MRI||
Biological: 18-FDG PET/CT, DWI, DCE-MRI
All patients on this study will receive a Diffuse Weighted MRI and Dynamic Contrast Enhancing MRI during the routine MRI session on the day of brachytherapy (additional 10 minutes), and a FDG PET/CT scanning session on the day of brachytherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01899404
|Contact: Kathy Han, MD||416 946 4501 ext 2919||Kathy.Han@rmp.uhn.on.ca|
|Contact: Michael Milosevic, MD||416 946 4501 ext 2932||Mike.Milosevic@rmp.uhn.on.ca|
|University Health Network, The Princess Margaret||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Kathy Han, MD 416 946 4501 ext 2919 Kathy.Han@rmp.uhn.on.ca|
|Contact: Michael Milosevic, MD 416 946 4501 ext 2932 Mike.Milosevic@rmp.uhn.on.ca|
|Principal Investigator: Michael Milosevic, MD|
|Sub-Investigator: Anthony Fyles, MD|
|Principal Investigator:||Kathy Han, MD||University Health Network, The Princess Margaret|