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Completed

NCT Number: NCT02308709

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ventilation image-guided radiotherapy

Radiation

Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions

Primary outcomes

  1. Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy

    Time frame: 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 outcomes

  1. Radiation Pneumonitis Graded by CTCAE v4.0

    Time frame: 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.

  2. Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline and 6 months

    The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.

  3. Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

    Time frame: Baseline and 6 months

    The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Dec 4, 2014
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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