Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
|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: NCT02434809|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : September 9, 2021
The first purpose of this study is to test a new computer program that reduces the blurring in the cone-beam CT scan and helps the doctor to better locate the tumor. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way we treat the cancer in the lungs.
The second purpose of this study is to test how well this computer program tracks markers in the images, compared to using radio signals to follow the markers.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: Bronchoscopic Implantation Device: Cone-Beam CT-Guided Radiation: stereotactic body radiation treatments||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Experimental: Patients with lung cancer
Physician evaluation of patient setup accuracy will be performed using all available images and adjustments will be made as per standard practice. In addition, a respiration motion-corrected CBCT (daily for SBRT, weekly for standard fractionation) will be used to confirm the accuracy of Calypso-based setup. Patients will return for follow up at 3,6, 9, 12, 15, 18, 21 and 24 months (+/- 4 weeks) following completion of radiation therapy. The following assessments will be performed at these visits: history and physical exam, diagnostic CT chest, and toxicity assessment.
Procedure: Bronchoscopic Implantation
Device: Cone-Beam CT-Guided
Radiation: stereotactic body radiation treatments
- successful Calypso transponder implantation [ Time Frame: 1 year ]The RapidTrack algorithm will be considered successful if the centroid position of the Calypso transponders, as determined by the RapidTrack algorithm, are within 2 mm of the positions determined by the Calypso system 95% of the 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): NCT02434809
|United States, New York|
|Memorial Sloan Kettering Cancer Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michael Lovelock, PhD||Memorial Sloan Kettering Cancer Center|