Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500513
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2007-07-10
Brief Title:
Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
To determine the safety of fiducial implantation
To determine the extentrate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue
To compare real-time portal imaging-based fiducial tracking with measurement of three-dimensional motion by four-dimensional CT scanning to determine how many fiducials are needed to track a tumor
To determine if intra-fractional lung tumor motion changes during a course of treatment and when during the treatment this occurs
To correlate the position of internal fiducials with the position of the external patient surface during respiration
To quantify the residual motion of the clinical target volume during radiotherapy gated using external fiducials
To verify the adequacy of the treatment portal margins in encompassing the residual motion of the clinical target volume
To determine if radio-opaque fiducial placement adjacent to the trachea which does not move can reduce daily setup inaccuracies and so spare normal tissue
To determine the motion of hilar adenopathy if any and whether it correlates with motion of the primary tumor
To determine the safety of fiducial implantation
To determine the extentrate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue
To compare real-time portal imaging-based fiducial tracking with measurement of three-dimensional motion by four-dimensional CT scanning to determine how many fiducials are needed to track a tumor
To determine if intra-fractional lung tumor motion changes during a course of treatment and when during the treatment this occurs
To correlate the position of internal fiducials with the position of the external patient surface during respiration
To quantify the residual motion of the clinical target volume during radiotherapy gated using external fiducials
To verify the adequacy of the treatment portal margins in encompassing the residual motion of the clinical target volume
To determine if radio-opaque fiducial placement adjacent to the trachea which does not move can reduce daily setup inaccuracies and so spare normal tissue
To determine the motion of hilar adenopathy if any and whether it correlates with motion of the primary tumor
Detailed Description:
If you are eligible to take part in this study you will have pulmonary lung function testing This testing will involve your breathing through a mouthpiece and measuring the amount of air you breathe This will provide information on how well your lungs work and how your chest wall moves when you breathe
You will then begin the normal treatment planning process A bean-bag cast will be made for you to lie in during planning and treatment This is done to lower day-to-day changes in your position A CT scan will be taken with you breathing quietly and possibly several X-rays will be performed as well You will be marked with magic marker and possibly have several permanent tattoos placed to help with daily positioning These procedures normally take 1-2 hours
Small metal markers up to 5 will then be placed near your tumor A thin flexible tube with a camera called a bronchoscope will be used to place these markers in your lungs You will be given a sedative through one of your veins and a local anesthetic will be sprayed in your nose and mouth before introducing the bronchoscope The bronchoscope is introduced through one of your nostrils and then passed into your windpipe and bronchial tubes This will allow the doctor to examine your lungs and place the small metal markers These markers will be used to track the tumor during treatment In this way the radiation treatment can be given to the tumor even if it moves while you breathe
You will also have studies to measure how much the tumor moves This will be done with several additional CT scans typically taken on a weekly basis Additional pulmonary function measurements will be taken during the CT scans These measurements will allow researchers to monitor the movement of your tumor when you breathe These procedures will normally take between 1 and 2 hours
You will be on this study for the duration of your radiation treatments You will be followed up an for an additional 4 - 6 weeks to make sure there are no complications from the study
THIS IS AN INVESTIGATIONAL STUDY A total of up to 30 patients will take part in this study All will be enrolled at M D Anderson
You will then begin the normal treatment planning process A bean-bag cast will be made for you to lie in during planning and treatment This is done to lower day-to-day changes in your position A CT scan will be taken with you breathing quietly and possibly several X-rays will be performed as well You will be marked with magic marker and possibly have several permanent tattoos placed to help with daily positioning These procedures normally take 1-2 hours
Small metal markers up to 5 will then be placed near your tumor A thin flexible tube with a camera called a bronchoscope will be used to place these markers in your lungs You will be given a sedative through one of your veins and a local anesthetic will be sprayed in your nose and mouth before introducing the bronchoscope The bronchoscope is introduced through one of your nostrils and then passed into your windpipe and bronchial tubes This will allow the doctor to examine your lungs and place the small metal markers These markers will be used to track the tumor during treatment In this way the radiation treatment can be given to the tumor even if it moves while you breathe
You will also have studies to measure how much the tumor moves This will be done with several additional CT scans typically taken on a weekly basis Additional pulmonary function measurements will be taken during the CT scans These measurements will allow researchers to monitor the movement of your tumor when you breathe These procedures will normally take between 1 and 2 hours
You will be on this study for the duration of your radiation treatments You will be followed up an for an additional 4 - 6 weeks to make sure there are no complications from the study
THIS IS AN INVESTIGATIONAL STUDY A total of up to 30 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None