Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

NCT04863027 | Completed DMC

• 1 other identifier: 14.003
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Lung Function Decreased; Radiation Pneumonitis

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Thoracic radiotherapy RADIATION

Patients will have pre-treatment and post-treatment perfusion DECT for baseline and post-treatment lung function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Varian Medical Systems: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2x 3E4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Respiratory Insufficiency; Radiation Pneumonitis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Interstitial; Lung Injury; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 28, 2021
• Study Start: January 1, 2015
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

CA (1)