CompletedNot applicableNCT02308709
Official study title

Novel Lung Functional Imaging for Personalized Radiotherapy

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedVentilation image-guided radiotherapy

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 10, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of California, Davis

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
University of California, Davis
Interventions being studied
Radiation: Ventilation image-guided radiotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Davis Medical CenterSacramento, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 10, 2022. Always confirm current availability with the study team.

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