Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

November 11, 2022 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

PHASE I-II Study on the Use of Dual Energy Computed Tomography for Assessment of Lung Function in Thoracic Conventional and Stereotactic Body Radiotherapy

This is a prospective observational study aiming: 1) To quantify lung function using perfusion dual energy computed tomography (DECT) and use this information at the time of treatment planning with preferential sparing of functional lung parenchymal 2) to validate results of lung function obtained using DECT with lung perfusion scintigraphy results, the current standard method; 4) to compare dosimetry of whole lungs vs. functional lungs in patients treated with either stereotactic body radiotherapy (SBRT) for early stage lung cancer or conventional radiotherapy for locally advanced lung cancer and 5) to evaluate lung function 6, 12 and 24 months post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with lung cancer planned for curative intent radiotherapy (conventional or stereotactic)

Description

Inclusion Criteria:

  • ≥ 18 years
  • ECOG 0-2
  • Pulmonary neoplasia, confirmed histopathologically or by imaging
  • Prognosis evaluated ≥ 1 year by attending MD
  • Clinically acceptable lung capacity to undergo radiotherapy
  • Initial assessment including history, physical examination, biochemistry, PFT, chest radiograph, chest and abdominal-pelvic scan, PET
  • Written consent
  • The patient must be available for treatment and monitoring. Patients registered in the study should be treated in our center.

Exclusion criteria

  • Previous radiotherapy in the radiation field
  • Presence of any major medical condition that, in the opinion of the investigator, would prevent follow-up at 6, 12 and 24 months post-radiotherapy.
  • Iodine allergy
  • Pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function quantification at baseline
Time Frame: Baseline
To quantify lung function using perfusion DECT and use this information at the time of treatment planning with preferential sparing of functional lung parenchyma.
Baseline
Radiation-induced lung function damage quantification
Time Frame: at 12 months after radiotherapy
To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.
at 12 months after radiotherapy
Radiation-induced lung function damage quantification
Time Frame: at 24 months after radiotherapy
To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.
at 24 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Varian Medical Systems

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 24, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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