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Completed

NCT Number: NCT01480973

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

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 outcomes

  1. Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC.

    Time frame: 2 years

    MRI pulse sequence settings

  2. MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC.

    Time frame: 2 years

    MRI tissue contrast

Secondary outcomes

  1. Reliability and reproducibility of thoracic MRI to distinguish between benign (fibrosis), malignant (recurrence), and indeterminate lung changes following SBRT for early-stage NSCLC.

    Time frame: 2 years

    Sensitivity, specificity, positive and negative predictive value

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2020
First posted
Nov 29, 2011
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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