Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Tran… (NCT02434809) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies
United States17 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.