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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04863027
Other study ID # 14.003
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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