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Stereotactic Body Radiotherapy (RT) for Non-Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have been treated at University of Health Network with SBRT for an early-stage NSCLC (T1N0M0; T2N0M0; or T3N0M0 chest wall primary tumours only).
  • On follow-up thoracic CT scans, patients must have changes in the previously targeted lung parenchyma that fit into one of the following three patterns: - Changes that on CT and clinical grounds are felt to be related to fibrosis
  • Changes that on CT and clinical grounds are suspicious for recurrence
  • Equivocal changes (uncertain whether the changes represent fibrosis or recurrence)
  • Must be greater than 18 years in age
  • Must be able to attend regular follow-up including radiologic investigations and clinical visits
  • Written informed consent

Exclusion Criteria:

  • Standard contraindications to MRI study (e.g. ferromagnetic prosthesis, pacemaker/implanted defibrillator, metallic implant in eye, severe claustrophobia, etc…)
  • Contraindications to Gadolinium contrast-agent. May include a history of allergic reaction to following previous administration of gadolinium or poor renal function (calculated creatinine clearance < 30 mL/min).
  • Patients with surgical resection of the treated portion of lung following their SBRT, although surgical resection of other parts of the lung is allowed.

Sites / Locations

  • Princess Margaret Hospital, University Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI post lung SBRT

Arm Description

Feasibility of MRI to differentiate between benign and malignant changes seen after lung SBRT.

Outcomes

Primary Outcome Measures

Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC.
MRI pulse sequence settings
MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC.
MRI tissue contrast

Secondary Outcome Measures

Reliability and reproducibility of thoracic MRI to distinguish between benign (fibrosis), malignant (recurrence), and indeterminate lung changes following SBRT for early-stage NSCLC.
Sensitivity, specificity, positive and negative predictive value

Full Information

First Posted
August 16, 2011
Last Updated
October 1, 2021
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01480973
Brief Title
Stereotactic Body Radiotherapy (RT) for Non-Small Cell Lung Cancer
Official Title
MRI Assessment of Post-Radiation Change Following Stereotactic Body RT for Non-Small Cell Lung Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
May 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

5. Study Description

Brief Summary
NSCLC is the leading cause of cancer mortality in North America, accounting for nearly 30% of all cancer deaths. The standard treatment for patients with early-stage non-small-cell lung cancer (NSCLC) is surgical resection of the involved lobe/lung. However, many patients are unable to undergo such a major surgery due to medical illness, and an emerging standard-of-care for these patients stereotactic-body radiation therapy (SBRT). SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few fractions (hypofractionation) to accurately describe, size-restricted malignant targets in which motion has been accounted for during the delivery process. SBRT administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI post lung SBRT
Arm Type
Experimental
Arm Description
Feasibility of MRI to differentiate between benign and malignant changes seen after lung SBRT.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few fractions (hypofractionation) to accurately delineated, size-restricted malignant targets in which motion has been accounted for during the delivery process. SBRT administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.
Primary Outcome Measure Information:
Title
Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC.
Description
MRI pulse sequence settings
Time Frame
2 years
Title
MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC.
Description
MRI tissue contrast
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Reliability and reproducibility of thoracic MRI to distinguish between benign (fibrosis), malignant (recurrence), and indeterminate lung changes following SBRT for early-stage NSCLC.
Description
Sensitivity, specificity, positive and negative predictive value
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have been treated at University of Health Network with SBRT for an early-stage NSCLC (T1N0M0; T2N0M0; or T3N0M0 chest wall primary tumours only). On follow-up thoracic CT scans, patients must have changes in the previously targeted lung parenchyma that fit into one of the following three patterns: - Changes that on CT and clinical grounds are felt to be related to fibrosis Changes that on CT and clinical grounds are suspicious for recurrence Equivocal changes (uncertain whether the changes represent fibrosis or recurrence) Must be greater than 18 years in age Must be able to attend regular follow-up including radiologic investigations and clinical visits Written informed consent Exclusion Criteria: Standard contraindications to MRI study (e.g. ferromagnetic prosthesis, pacemaker/implanted defibrillator, metallic implant in eye, severe claustrophobia, etc…) Contraindications to Gadolinium contrast-agent. May include a history of allergic reaction to following previous administration of gadolinium or poor renal function (calculated creatinine clearance < 30 mL/min). Patients with surgical resection of the treated portion of lung following their SBRT, although surgical resection of other parts of the lung is allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cho, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Stereotactic Body Radiotherapy (RT) for Non-Small Cell Lung Cancer

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