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
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Respiratory Motion-Corrected Cone-Beam CT
Radiation
14-225
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: successful Calypso transponder implantation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Zhang Peng, PhD
role: PRINCIPAL_INVESTIGATOR
References: