Cone Beam Computed Tomography (CT) (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID)
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|ClinicalTrials.gov Identifier: NCT00937248|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2009
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Device: prone pillow and simple ankle fixation device Device: Customized Vacuum Immobilization Device (CVID)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study Evaluating Set-up Reproducibility Using Cone Beam CT (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID) in Rectal Cancer Patients Treated With Preoperative Pelvic Radiation Therapy|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2020|
Patient randomized to be immobilized using a prone pillow and simple ankle fixation device with a CVID.
Device: Customized Vacuum Immobilization Device (CVID)
This device is a bean bag like cushion that is placed from the abdomen to the thighs. When a patient is comfortably lying on this device, air within the bag is suctioned out resulting in an impression or cast of a patient.
Active Comparator: Standard Arm
Patient randomized to be immobilized using a prone pillow and simple ankle fixation device without a CVID
Device: prone pillow and simple ankle fixation device
Patients will lie face down (prone) on a soft cushion made of foam under their face and upper chest. Additionally, there is a foam support placed at the ankles.
- Comparing the use of a prone pillow and simple ankle fixation device vs. the use of a CVID for immobilization rectal patients during the course of preoperative radiation therapy using KV CBCT for IGRT. [ Time Frame: 2 years ]
- quantify interfractional set-up displacements using either of the two devices;determine a standard planning target volume margin; evaluate the role of soft-tissue image matching for IGRT using CBCT. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937248
|University Health Network, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||John Kim, MD||University Health Network, Princess Margaret Hospital|