Tracking of Respiratory-Induced Tumor Motion Using Implanted Fiducials
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00500513|
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : February 1, 2013
- To determine the safety of fiducial implantation.
- To determine the extent/rate 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.
|Condition or disease||Intervention/treatment|
|Lung Cancer||Procedure: CT Scans Procedure: Implanted markers Radiation: Radiation Treatment (RT)|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion|
|Study Start Date :||April 2004|
|Primary Completion Date :||June 2007|
|Study Completion Date :||December 2011|
|Experimental: Implanted Markers + CT + RT||
Procedure: CT Scans
CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.
Other Names:Procedure: Implanted markers
Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscopeRadiation: Radiation Treatment (RT)
Radiotherapy incorporating respiratory treatment delivery
- Number of patients experiencing motion of one or more fiducials during the course of radiation therapy [ Time Frame: Baseline, 6 weeks ]
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): NCT00500513
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Starkschall, PhD||M.D. Anderson Cancer Center|