Feasibility Study of Navigated Endoscopy for the Placement of High Dose Rate Brachytherapy Applicators in the Esophagus and Lung
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|ClinicalTrials.gov Identifier: NCT03051802|
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 14, 2017
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Esophagus Cancer Lung Cancer||Device: Navigated Endoscopy||Not Applicable|
High dose rate brachytherapy is used in a limited number of esophagus and lung patients, often in combination with external beam radiation therapy. The procedure uses an applicator inserted into the lumen with the applicator connected to an automated "afterloader", a device with a radioactive brachytherapy source attached to a thick guide wire that positions the source within the applicator at set positions and times based on a treatment plan. Identification of the ideal applicator position is determined by white light endoscopy. With the endoscope in the lumen, fluoroscopic imaging can visualize the endoscope position. Temporary radio-opaque skin markers are placed on the patient's anterior surface under fluoroscopy imaging so that they align with the endoscope tip. The proximal and the distal ends of the target volume are marked in this manner by the surgeon stopping the endoscope at these positions. The endoscope is removed and the applicator inserted, with the positions of the applicator and "dummy" seeds (i.e. non-radioactive seeds used only for positioning purposes) aligned under fluoroscopy to match the skin markers. The procedure has 2 disadvantages: i. There is extra radiation dose to the clinical staff due to the fluoroscopy used to identify the source position.
ii. Visualization is only in 2D, which is inaccurate since it does not account for separations in the vertical direction and the angle of projection between the applicator and the so patient surface. Furthermore, any movement of the fluoroscopy device during the insertion leads to errors in visualization.
Medical applications of navigated endoscopy continue to grow, especially when used in combination with volumetricimaging for image-guided procedures. This feasibility study is aimed to use navigation endoscopy technology to overcome the disadvantages of the current practice and improve the overall process.
In the proposed protocol, applicator insertion, tracking and recording of the endoscope and applicator positions would enable placement of the applicator using 3D information, with greater accuracy and without extra radiation dose to the clinical staff. The tracking technology would be used to replace the use of radio-opaque skin markers; rather than placing these markers on the patient's skin, the location of the target volume boundaries would be noted by the tracker position within the endoscope. Applicator insertion would also be tracked, with the applicator positioning based on the location of the applicator relative to the previously recorded endoscope positions, including the locations of the distal and proximal ends of the target volume.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study of Navigated Endoscopy for the Placement of High Dose Rate Brachytherapy Applicators in the Esophagus and Lung|
|Actual Study Start Date :||January 27, 2017|
|Actual Primary Completion Date :||April 24, 2018|
|Actual Study Completion Date :||April 24, 2018|
- Device: Navigated Endoscopy
Navigated endoscopy used to guide the placement of HDR applicators in the esophagus or lung as a replacement to current standard of practice using fluoroscopic imaging.
- proportion of navigated endoscopy procedures that were successfully completed [ Time Frame: 18 months ]
To assess clinical feasibility of inserting intraluminal (esophagus or lung) HDR applicators using navigation technologies for tracking endoscope and applicator insertion.
This study is designed to assess the workflow when using the EM tracking technology and the accuracy of the procedure will be measured by comparison with current standard of care.
- Positional accuracy [ Time Frame: day 1 ]To compare the positional accuracy of the navigation procedure versus the current standard of care using 2D fluoroscopy using analysis of tracking data. All tracking data will be recorded for post-procedure analysis and comparison with the fluoroscopic imaging performed during current standard of care
- Optimize the clinical protocol using this technology [ Time Frame: 6 months ]The procedure will be assessed in detail (based on time and workflow) after three patients. Participants in the review of the procedure will include surgeon, radiation oncologist, brachy-therapists and physicists. Workflow improvements will be implemented at this time.
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): NCT03051802
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|