Ignite Creation Date:
2024-05-06 @ 8:14 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02695680
Status:
TERMINATED
Last Update Posted:
2024-05-08
First Post:
2016-02-18
Brief Title:
Lung SBRT Motion Management GCC 1619
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding for this study is over and the PI has request closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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 andor 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 Sawants 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
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 Sawants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None