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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bronchoscopic Implantation

Intervention Type PROCEDURE

Calypso transponders

Cone-Beam CT-Guided

Intervention Type DEVICE

stereotactic body radiation treatments

Intervention Type RADIATION

Interventions

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Bronchoscopic Implantation

Calypso transponders

Intervention Type PROCEDURE

Cone-Beam CT-Guided

Intervention Type DEVICE

stereotactic body radiation treatments

Intervention Type RADIATION

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No