Novel Lung Functional Imaging for Personalized Radiotherapy



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:3/23/2019
Start Date:September 2014
End Date:January 2020
Contact:Tokihiro Yamamoto, Ph.D.
Email:tokihiro.yamamoto@ucdmc.ucdavis.edu
Phone:916-734-0604

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The primary objective of this study is to assess the safety and feasibility of personalized
radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation
imaging, which selectively avoids irradiating highly-functional lung regions.

In this clinical trial, the investigators will assess the safety and feasibility of 4D CT
ventilation image-guided personalized radiotherapy. The investigators will deliver
personalized radiotherapy treatments that selectively avoid irradiating highly-functional
lung regions for lung cancer patients, and follow up patients to assess the safety and
feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided
personalized radiotherapy can be delivered safely for lung cancer.

Inclusion Criteria:

- Primary lung cancer or metastatic disease to the lungs to be treated with either
conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic
ablative radiotherapy (SABR).

- Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age.
There are no gender or ethnic restrictions.

- Concurrent chemotherapy is allowed, but not required.

- Life expectancy with treatment should be ≥6 months in the estimation of the treating
physicians.

- Zubrod performance status ≤2

- Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500;
LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50

- Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

- Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of
planned radiotherapy fields.

- For patients undergoing definitive CFRT, patients with distant metastatic disease are
not eligible.

- For patients undergoing SABR, both early stage primary lung cancer patients and those
with limited metastatic disease to the lungs are eligible; however, patients with
oligometastatic disease should have a controlled primary and no more than one other
involved organ system.

- Children (<18 years of age), pregnant women, University of California employees or
students, or prisoners will be excluded from this study.
We found this trial at
1
site
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Phone: 916-734-0604
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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mi
from
Sacramento, CA
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