Summary

for people ages 18-80 (full criteria)
at UC Davis
study started
estimated completion:
Tokihiro Yamamoto (ucdavis)

Description

Summary

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.

Official Title

Novel Lung Functional Imaging for Personalized Radiotherapy

Details

In this clinical trial, we will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. We 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.

Keywords

Lung Cancer Radiotherapy Pulmonary Functional Imaging Computed Tomography (CT) Image Registration Functional Image-guided Radiotherapy Ventilation image-guided radiotherapy

Eligibility

You can join if…

Open to people ages 18-80

  • 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.

You CAN'T join if...

  • 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.

Location

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT02308709
Study Type
Interventional
Last Updated