Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

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: Lung Cancer; Radiation Pneumonitis; Lung Function Decreased
• Intervention / Treatment: Radiation: Thoracic radiotherapy

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

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

Participation Criteria

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

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	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	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	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

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Varian Medical Systems

Study record dates

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: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Pneumonia; Radiation Pneumonitis
• 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