Novel Lung Functional Imaging for Personalized Radiotherapy

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: Ventilation image-guided radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy	Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Pneumonitis Graded by CTCAE v4.0	Number of participants with Grade ≥ 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.	2 years
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)	The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.	Baseline and 6 months
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Tokihiro Yamamoto, Ph.D., University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2014
• Primary Completion (Actual): November 19, 2020
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Radiotherapy; Pulmonary Functional Imaging; Computed Tomography (CT); Image Registration; Functional Image-guided Radiotherapy
• Other Study ID Numbers: 472677; CCRO030 (Other Identifier: UC Davis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No