Clinical trial NCT02695680: Lung SBRT Motion Management (GCC 1619)
Official title: Modeling Respiration-induced Motion and Deformation of Tumors and Thoracic Organs for Personalized Motion Management in Lung SBRT
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: Lung Cancer
SBRT
Motion Management
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Maryland
First posted: 2016-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or metastatic lung lesions

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who demonstrate significant motion movement during radiation therapy.
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Ummc Msgcc
state: Maryland
city: Bel Air
country: United States
facility: Upper Chesapeake Health
state: Maryland
Study officials:
affiliation: University of Maryland
name: Amit Sawant, PhD
role: PRINCIPAL_INVESTIGATOR
References: