Perfusion CT Imaging in Lung Cancer With SBRT
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Perfusion CT Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Gender: male or female
- CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
- Patient will sign a consent form prior to study entry
- Lung cancer and lung metastases are biopsy proven
Exclusion Criteria:
- Patients who are unable to give valid informed consent
- Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.
Sites / Locations
- Patrik Rogalla
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
open label
Arm Description
Perfusion CT Imaging
Outcomes
Primary Outcome Measures
Imaging of during and after SBRT treatment for lung malignancies with a combined perfusion and routine CT to assess therapy response of lung cancer and metastases.
Secondary Outcome Measures
Full Information
NCT ID
NCT02755454
First Posted
March 7, 2016
Last Updated
November 20, 2018
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02755454
Brief Title
Perfusion CT Imaging in Lung Cancer With SBRT
Official Title
Perfusion CT Imaging in Patients With Lung Malignancies Receiving Stereotactic Body Radiation Therapy (SBRT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Other
Arm Description
Perfusion CT Imaging
Intervention Type
Device
Intervention Name(s)
Perfusion CT Imaging
Primary Outcome Measure Information:
Title
Imaging of during and after SBRT treatment for lung malignancies with a combined perfusion and routine CT to assess therapy response of lung cancer and metastases.
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gender: male or female
CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
Patient will sign a consent form prior to study entry
Lung cancer and lung metastases are biopsy proven
Exclusion Criteria:
Patients who are unable to give valid informed consent
Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrik Rogalla, MD
Organizational Affiliation
UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patrik Rogalla
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2X9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Perfusion CT Imaging in Lung Cancer With SBRT
We'll reach out to this number within 24 hrs