Novel Lung Functional Imaging for Personalized Radiotherapy

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Radiation: Ventilation image-guided radiotherapy

• Registration Number: NCT02308709
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09-15
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2020-11-19
• Study Completion: 2021-11-19
• Results First Submitted: 2022-08-04
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Results First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ventilation image-guided radiotherapy	Ventilation image-guided radiotherapy	Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions

Primary Outcome Measures

Name	Time	Method
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Radiation Pneumonitis Graded by CTCAE v4.0	2 years	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.
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)	Baseline and 6 months	The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)	Baseline and 6 months	The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States