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Novel Lung Functional Imaging for Personalized Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02308709
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: Ventilation image-guided radiotherapy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Lung Functional Imaging for Personalized Radiotherapy
Actual Study Start Date : September 15, 2014
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ventilation image-guided radiotherapy
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Radiation: Ventilation image-guided radiotherapy
Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions




Primary Outcome Measures :
  1. Grade ≥3 AEs defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Radiation pneumonitis graded by CTCAE v4.0 [ Time Frame: 2 years ]
  2. Post-treatment change in forced expiratory volume in 1 second (FEV1) [ Time Frame: 6 months ]
  3. Post-treatment change in diffusing capacity [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308709


Locations
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United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Tokihiro Yamamoto, Ph.D. University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02308709    
Other Study ID Numbers: 472677
CCRO030 ( Other Identifier: UC Davis )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Davis:
Radiotherapy
Pulmonary Functional Imaging
Computed Tomography (CT)
Image Registration
Functional Image-guided Radiotherapy