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

Non Small Cell Lung Cancer Clinical Trial

Official title:

MRI Assessment of Post-Radiation Change Following Stereotactic Body RT for Non-Small Cell Lung Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480973
• Other study ID #: UHN REB 11-0079-CE
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: May 29, 2020

Study information

• Verified date: October 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 29, 2020
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• Stereotactic Body Radiation Therapy
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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC.	MRI pulse sequence settings	2 years
Primary	MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC.	MRI tissue contrast	2 years
Secondary	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	2 years