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Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies

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ClinicalTrials.gov Identifier: NCT02434809
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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.
Procedure: Bronchoscopic Implantation
Calypso transponders

Device: Cone-Beam CT-Guided
Radiation: stereotactic body radiation treatments



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Gikas Mageras, PhD 646-888-8007
Contact: Andreas Rimner, MD 212-639-6025

Locations
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United States, New York
Memorial Sloan Kettering Cancer Commack Recruiting
Commack, New York, United States, 11725
Contact: Gikas Mageras, PhD    646-888-8007      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Gikas Mageras, PhD    646-888-8007      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Gikas Mageras, PhD    646-888-8007      
Contact: Andreas Rimner, MD    212-639-6025      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Gikas Mageras, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02434809     History of Changes
Other Study ID Numbers: 14-225
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Respiratory Motion-Corrected Cone-Beam CT
Radiation
14-225