An observational study in Lung Cancer, sponsored by University of Maryland, Baltimore. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Maryland, Baltimore · Observational
Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). A patient-specific 4D model will be developed using the raw 4DCT projections time-correlated with real-time surface monitoring. In addition, before delivering each dose fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions, time-correlated with optical surface monitoring. The acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.
Surface monitoring procedure -The procedure is expected to last approximately 15 minutes after the end of the 4DCT scan, which is the standard-of-care for lung SBRT treatments at our institution. The procedure will consist of real-time surface tracking using the VisionRT system of the thoracic and/or abdominal region. Continuous audiovisual contact will be maintained with the subject during scanning. Each individual will be informed that they can stop the procedure at any point.
Fluoroscopic imaging procedure - Fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. Three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kV imager. Audiovisual contact will be maintained at all times with the patient.
Data collection and management: An ID number will be assigned to each separate patient, and the correlation between ID number and patient name and medical record number will be kept in a password-protected file in Dr. Amit Sawant's office. The database of information extracted from the medical record and radiation treatment records for each patient will be stored in an Excel file on a computer with password protection. All image data will be de-identified by Dr. Sawant before his research team analyzes them.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 40 is below the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Patients with primary or metastatic lung lesions
Exclusion Criteria:
Respiratory motion causes significant geometric and dosimetric errors in the administration of lung stereotactic radiotherapy (SBRT). The purpose of this study is to create and validate patient-specific motion models of the thoracic anatomy with high spatial and temporal resolution. These models will be used to develop novel four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.
Number of participants who demonstrate significant motion movement during radiation therapy.
Develop novel Four-dimensional (4D=3D+time) techniques for radiotherapy treatment planning and real-time motion-adaptive dose delivery.
Time frame: 1.5 years
Plan to share: No
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore