Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863027
• Other study ID #: 14.003
• Status: Completed
• Start date: January 2015
• Est. completion date: November 2022

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Function Decreased
• Pneumonia
• Radiation Pneumonitis

Intervention

Radiation:
• Thoracic radiotherapy
Patients will have pre-treatment and post-treatment perfusion DECT for baseline and post-treatment lung function

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Varian Medical Systems

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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