- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434809
Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Commack
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologic proof of malignancy suitable for thoracic radiation therapy
- Patient is planning to undergo radiation therapy for primary or recurrent malignancies of the lung or metastatic malignancies to the lung.
- Age ≥ 18 years old
- Karnofsky Performance Status ≥ 60%
- At least part of the tumor must be visible as observed in a diagnostic or planning CT.
- Able to have bronchoscopic placement of Calypso transponders as confirmed on a recent (within the past 8 weeks) CT scan.
Exclusion Criteria:
- Patients with clinically significant active infections.
- Bronchiectasis in the region of the intended implantation.
- History of hypersensitivity to nickel.
- Other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
- Deemed unable to safely undergo or tolerate flexible bronchoscopy as per institutional guidelines
- Unable to tolerate anesthesia or sedation
- Enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
- Female patients who are pregnant or nursing
Exclusion criteria for Calypso transponders:
- Implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
- Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
- Patients whose lung tumors are being monitored by MR imaging as part of standard clinical care. Implantation of transponders will degrade MR images.
- Posterior lesions that would be >19 cm distance from Calypso detector plate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Calypso transponders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zhang Peng, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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