Diagnostic Trials

1. Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)

      ClinicalTrials.gov Identifier:             NCT01786590      
 
This study is currently recruiting participants
 
Ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.
 
Ontario 
University Health Network
 

2. Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay (LU-NGS-2)

       ClinicalTrials.gov Identifier:              NCT03558165      

This study is currently recruiting participants
 
Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.
 
Ontario
Princess Margaret Hospital, Toronto 

3. Circulating Tumour DNA in Lung Cancer (CITaDeL): Optimizing Sensitivity and Clinical Utility (CITaDeL)

      ClinicalTrials.gov Identifier:             NCT03986463      

This study is currently recruiting participants
 
This is a prospective observation study in patients with non-small cell lung cancer (NSCLC) starting either cytotoxic chemotherapy or radiation therapy. It will assess changes in circulating tumor DNA (ctDNA) in the days following the initiation of treatment, as well as longitudinal monitoring, to assess the dynamics and value of ctDNA in stage III-IV NSCLC.
 
Ontario
London Regional Cancer Program. London

4. Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer

      ClinicalTrials.gov Identifier:             NCT01487603     

This study is currently recruiting participants
 
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples obtained during diagnosis of lung cancer can be used for molecular analysis that will predict response to treatment and prognosis. In this study, we will detect specific target molecules related to the effectiveness of treatment (surgery, chemotherapy, radiotherapy) and prognosis in patients with lung cancer using EBUS-TBNA samples and its combined with xenograft technology.
 
Ontario 
University Health Network
 

5. Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath

      ClinicalTrials.gov Identifier:             NCT03809169      

This study is currently recruiting participants
 
Rapid on-site evaluation of biopsy samples by a cytopathologist (ROSE) allows for direct evaluation of specimen adequacy. By offering real-time feedback to the bronchoscopist about specimen adequacy, the adding of ROSE to pEBUS could lead to an increase in diagnostic yield, allowing for a faster diagnosis of lung cancer and avoiding the need for further diagnostic procedures. Minitiazuration of broncoscopes can also allow navigation to more distal areas of the lung closer to the PPL. While this may also improve diagnostic yield, other technical modification such as the need for smaller sampling instruments and inability to use a guide sheath may have drawbacks.
 
This study will use a 2 x 2 factorial design to compare diagnostic yield of pEBUS bronchoscopic PPL sampling with vs. without ROSE as well as with a novel "slim" bronchoscope vs. standard bronchoscope. The investigators aim to randomize 208 patients to independently test each hypothesis.
 
Alberta
Health Sciences Centre, Calgary

6. Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-small Cell Lung Cancer

      ClinicalTrials.gov Identifier:             NCT01507428      

This study is currently active, but not recruiting participants
 
This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) scan work in guiding radiation therapy compared to standard radiation therapy treatment in patients with stage III non-small cell lung cancer. Imaging procedures, such as PET scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.
 
Quebec 
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6
 
Saskatchewan
Saskatoon Cancer Centre
 

7. Screening of Alberta Asbestos Exposed Workers for Lung Cancer and Mesothelioma

      ClinicalTrials.gov Identifier:             NCT02385812      

This study is currently recruiting participants
 
Asbestos defines a group of naturally occurring mineral silicate fibers which are easily inhaled, resulting in a variety of diseases of the respiratory system including lung cancer and malignant mesothelioma. Despite some advances in treatment, there has been little impact on overall survival for both lung cancer and mesothelioma in the past 20 years in great part because patients usually present with disease at an advanced and incurable stage. This study aims to develop and implement a low-dose computed tomography (LDCT) screening approach for lung cancer and mesothelioma in asbestos-exposed workers in Alberta.
 
Alberta 
University of Calgary
 

8. Alberta Lung Cancer Screening Program

      ClinicalTrials.gov Identifier:             NCT02431962      

This study is currently active, but not recruiting participants
 
Lung Cancer is the leading cause of cancer death in North America and in the world. The vast majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority of lung cancers are detected at an advanced stage when they have a very poor prognosis. A substantial amount of data has been reported on low-dose computed tomography (LDCT) screening. Yet endorsement of lung cancer screening has not been universal because of outstanding concerns which need to be addressed. Our study will aim to screen at risk Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to fill some knowledge gaps on this topic.
 
Alberta 
Calgary
Edmonton
 

9. Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT (SBRT FLT-PET)

     ClinicalTrials.gov Identifier:             NCT02456246      

This study is currently recruiting participants
 
Stereotactic body radiotherapy (SBRT) has demonstrated an impressive 3-year control rate of higher than 90% for early stage NSCLC, leading to increased use of this technique as a curative method for lung cancer treatment. With growing clinical experience with this technique, post-SBRT follow up has received more attention. Follow up after SBRT is done primarily by thorax CT, which is affected by radiation-induced radiographic lung changes that can resemble or obscure local recurrence.
 
FLT (3'-deoxy-3'-fluorothymidine) is a thymidine analogue which is non-toxic in tracer doses, and can be labeled with 18F. FLT-PET is a type of imaging (similar concept to the widely used 18-FDG PET-CT) that is based on integration of thymidine into DNA for assessment of proliferation. Conceptually, increased DNA synthesis is correlated to tumor aggressiveness and response to therapy, more so than glucose utilization - as in FDG-PET could be.
 
The purpose of this study is therefore to see what added information the use of FTL-PET can provide in distinguishing between changes in the lung that occur as a result of treatment that are not cancerous and those that are due to recurrence or progressive disease.
 
Ontario 
University Health Network
 

10. Cone-beam CT Guided Microcoil Localization of Pulmonary Nodules During Video Assisted Thoracic Surgery(VATS)

      ClinicalTrials.gov Identifier:             NCT02496624      

This study is currently recruiting participants
 
The Guided Therapeutics (GTx) program at the University Health Network is a network of clinicians, scientists, and engineers focused on the development and translation of image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies developed within the GTx program include a portable intra-operative cone-beam CT (in collaboration with Siemens) that has been evaluated in clinical trials for head and neck surgery. The intraoperative imaging has been integrated with tracking and navigational tools and optical imaging to provide a general "surgical dashboard" that is used to improve the accuracy of surgical resection.
 
A recent addition to the GTx program is the development of the GTx OR, located within the general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy Somatom Flash provides a "gold-standard" in CT imaging, while the Zeego provides excellent 3D Cone-beam CT with robotic placement for flexible integration within the operating environment. Together, the integration of these 2 components into a single OR enables critical evaluation of the limits of CT imaging technology for surgical guidance.
 
This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement and localization of markers for resection of small pulmonary nodules during VATS.
 
Ontario 
University Health Network
 

11. 18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung Cancer

      ClinicalTrials.gov Identifier:             NCT02701699      

This study is currently recruiting participants
 
The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans can provide useful information about hypoxia in lung cancer.
 
In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior to their first radiotherapy treatment
 
Ontario 
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
 

12. Feasibility of Multi-Energy Digital Radiography Detector for Lung Lesions Detection

      ClinicalTrials.gov Identifier:             NCT03528733      

This study is currently recruiting participants
 
A feasibility study is proposed to investigate the imaging characteristics captured by a Single Exposure Dual-Energy Subtraction digital radiography with KA Imaging's Multi-energy detector.
 
Ontario
Grand River Hospital, Kitchener
 

13. Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

      ClinicalTrials.gov Identifier:             NCT01595074      

This study is not yet recruiting participants
 
This research trial studies biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related tocancer. It may also help doctors predict how patients will respond to treatment.
 
 
Ontario
National Cancer Institute of Canada Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6

Contact: Lesley K. Seymour 613-533-6430
lseymour@ctg.queensu.ca  
Principal Investigator: Lesley K. Seym
 

14. Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients With NSCLC

      ClinicalTrials.gov Identifier:             NCT04093167    
 
This study is currently recruiting participants
 
The purpose of stage 1 of the study is to find out if blood tests can be used to see how the cancer is responding to treatment with pembrolizumab.
 
British Columbia
BC Cancer - Vancouver Cancer Centre
 
Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Ottawa Hospital Research Institute
University Health Network

15. Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD)

      ClinicalTrials.gov Identifier:             NCT03485378     

This study is currently recruiting participants
   
This is a prospective phase II study of Stereotactic Ablative Radiotherapy (SABR) in patients with Non-Small Cell Lung Cancer (NSCLC) and co-existent Interstitial Lung Disease (ILD), to determine oncologic and toxicity outcomes. Patients will be divided into 3 separate cohorts based on the ILD-GAP index.
 
Ontario
London Regional Cancer Program of the Lawson Health Research Institute
UHN Princess Margaret Cancer Centre
 
Quebec
CHUM Université de Montréal

16. Pulmonary Physiology and Systemic Inflammatory in EO Pulmonary Events With Brigatinib Use in NSCLC and Other Diseases

      ClinicalTrials.gov Identifier:             NCT03389399    

This study is currently recruiting participants
 
     This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Participants who enroll on this study protocol will either be taking brigatinib in the context of an ongoing clinical trial, or as part of standard of care treatment as licensed by FDA.
 
Ontario
Princess Margaret Hospital, Toronto