Lung SBRT Motion Management (GCC 1619)

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Ummc Msgcc
    • Bel Air, Maryland, United States, 21014
      • Upper Chesapeake Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or metastatic lung lesions

Description

Inclusion Criteria:

1. Eligible disease(s)/stage(s) - Patients with primary or metastatic lung lesions to be treated using stereotactic body radiotherapy (SBRT) will be eligible for this study.
2. Allowable type and amount of prior therapy - Any types and amounts of prior therapy will be allowed for this study.
3. Age restriction and/or gender/ethnic restrictions - Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
4. Life expectancy restrictions - None.
5. ECOG or Karnofsky Performance Status - Karnofsky performance status of 50 or greater
6. Requirements for organ and marrow function - None.
7. Ability to understand and the willingness to sign a written informed consent document.
8. Tumor motion > 5 mm, maximum GTV dimension < 50 mm - per guidelines established by the AAPM Task Group 7612 and RTOG 0236.13

Exclusion Criteria:

1. Children (age <18)
2. Women who are pregnant or trying to get pregnant
3. Pain in supine position
4. Karnofsky performance status < 50

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Lung SBRT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1.5 years

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: University of Maryland
• Investigators: Principal Investigator: Amit Sawant, PhD, University of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimated): March 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer; SBRT; Motion Management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HP-00068540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No