Lung SBRT Motion Management (GCC 1619)



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/13/2018
Start Date:October 27, 2017
End Date:December 2022
Contact:Bahiyyah Jackson, MS
Email:bjackson1@umm.edu
Phone:410-328-7586

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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.

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.

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
We found this trial at
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500 Upper Chesapeake Drive
Bel Air, Maryland 21014
Phone: 443-643-1877
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Bel Air, MD
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Baltimore, Maryland 21201
Principal Investigator: Amit Sawant, PhD
Phone: 410-328-7586
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Baltimore, MD
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