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NCT Number: NCT04863027

Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Diseases, Interstitial Lung Function Decreased Lung Injury Lung Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiation Pneumonitis Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2x 3E4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thoracic radiotherapy

Radiation

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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