Clinical Trials Directory

Trials / Terminated

TerminatedNCT02695680

Lung SBRT Motion Management (GCC 1619)

Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT

Status
Terminated
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
University of Maryland, Baltimore · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2017-10-27
Primary completion
2024-01-04
Completion
2024-01-04
First posted
2016-03-01
Last updated
2024-05-08

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02695680. Inclusion in this directory is not an endorsement.