Lung SBRT Motion Management (GCC 1619)

NCT02695680 | Terminated DMC

• 1 other identifier: HP-00068540
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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, e.g., every 4th angle for a 12-field plan.

Conditions

Lung Cancer

Keywords

Lung Cancer; SBRT; Motion Management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or metastatic lung lesions

You may qualify if:

• 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.
• Allowable type and amount of prior therapy - Any types and amounts of prior therapy will be allowed for this study.
• 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.
• Life expectancy restrictions - None.
• ECOG or Karnofsky Performance Status - Karnofsky performance status of 50 or greater
• Requirements for organ and marrow function - None.
• Ability to understand and the willingness to sign a written informed consent document.
• Tumor motion \> 5 mm, maximum GTV dimension \< 50 mm - per guidelines established by the AAPM Task Group 7612 and RTOG 0236.13

You may not qualify if:

• Children (age \<18)
• Women who are pregnant or trying to get pregnant
• Pain in supine position
• Karnofsky performance status \< 50

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Maryland: collaborator

Study Sites (2)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

Upper Chesapeake Health

Bel Air, Maryland, 21014, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Amit Sawant, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 1, 2016
• Study Start: October 27, 2017
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)