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Novel Lung Imaging in Adults Undergoing Radiation Therapy to Assess for Radiation Pneumonitis

NCT02735746 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-08-22

No results posted yet for this study

Summary

The purpose of this study is to to compare lung function data generated by applying High Fidelity Functional Lung Imaging (HFFLI) software to 4D CT, cone beam CT, and fluoroscopic images of the lungs breathing to determine whether different modalities of imaging provide similar data on lung movement and function. HFFLI may detect changes in lung function in patients undergoing External Beam Radiotherapy for cancer.

Conditions

Interventions

RADIATION

4D Computed Tomography (CT)

The initial 4DCT imaging obtained as part of a subject's planning CT for their standard radiation treatment.

RADIATION

Cone Beam CT

Daily cone beam CT imaging at each radiation treatment visit, as part of standard care

RADIATION

Low-dose Cinefluorography

A series of images consisting of five six-second cinefluorographs (real time fluoroscopic movies, for a total each time of 30 seconds of fluoroscopy) of the lungs while the subject is breathing, each at precisely measured angles to the subject, on 4 different occasions.

DEVICE

Pulmonary Function Tests

Pulmonary Function Testing (PFT) gives global functional data for the lungs as a whole, but is relatively insensitive to early pathological changes. It involves taking very deep breaths and exhaling as forcefully as possible. Research PFTs will be conducted at 4 and 12-months post radiation therapy

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Stephen Shiao, MD, PhD · Cedars-Sinal Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-21
Primary Completion
2025-06-06
Completion
2025-06-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02735746 on ClinicalTrials.gov