An observational study in Non-small Cell Lung Cancer and Radiation Toxicity, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Observational
Among 660 studies in Carcinoma, Non-Small-Cell Lung with a site in Canada — 107 open to participants now, 230 under way, 98 of them phase 3. Carcinoma, Non-Small-Cell Lung · Canada.
Among the 660 studies in Carcinoma, Non-Small-Cell Lung with a site in Canada, this one is the 27th largest by planned enrollment of the 32 observational ones that give a count, is one of 35 that started in 2018, is one of 32 observational ones, and was the 359th registered.
7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,836 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →107 of the 660 studies in Carcinoma, Non-Small-Cell Lung with a site in Canada are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Canada, United States, Argentina and 16 more countries
Ages 18+
Bristol-Myers Squibb · Sites in Canada, United States, Argentina and 13 more countries
Ages 18+
AHS Cancer Control Alberta · Sites in Canada
Ages 18+
Centre hospitalier de l'Université de Montréal (CHUM) · Sites in Canada
Ages 18+
Janssen Research & Development, LLC · Sites in Canada, United States, China and 3 more countries
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 1,327 Carcinoma, Non-Small-Cell Lung studies recruiting now, 989 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
660 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 184 · Phase 2 249 · Phase 3 236 · Phase 4 3
First in 1994; this study’s year is marked. 35 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 190 across the 613 interventional studies, 100 across the 32 observational. Of the 404 that completed or were terminated, 205 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
481 of 660 have an industry lead sponsor. The 10 most frequent:
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's has 3 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
53 of the studies in Carcinoma, Non-Small-Cell Lung with a site in Canada that are under way reach primary completion within a year, 16 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
| NCT05609968Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) | 2027-01-12 |
| NCT06140836Phase 3Bristol-Myers SquibbA Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) | 2027-02-16 |
| NCT04380636Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) | 2027-05-05 |
Add all 53 to your calendar (.ics) → With an account.
Among the 660 studies in Carcinoma, Non-Small-Cell Lung with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Lung cancer is the most common cause of cancer death in Canada. For approximately 30% of patients that present with locally-advanced non-small cell lung cancer (NSCLC), the standard treatment is curative-intent concurrent chemoradiotherapy. Outcomes remain poor, with 5-year survival of only 20%. Despite the long-held belief that higher radiation doses lead to improved overall survival (OS), the landmark randomized trial (RTOG 0617) showed the opposite. The investigators hypothesize that the inferior survival observed may be due to unexpected heart toxicity as secondary analysis revealed that the heart dose was a strong predictor of inferior OS. Up to now, change in heart function is typically detected histologically, requiring autopsy tissue. Therefore, a non-invasive marker of early heart damage is required. Hybrid PET-MRI has become available in Canada only recently. The ability to simultaneously perform metabolic imaging with functional and tissue imaging allows for novel assessment of heart toxicity. The primary objective is to examine the utility of hybrid PET-MRI and DCE-CT to assess acute changes in heart function and to measure inflammation before, and six weeks after NSCLC radiotherapy. A pilot of 20 patients with Stage I-III NSCLC will be enrolled. The findings of this study will aid in the design of new studies to reassess dose escalation for locally advanced NSCLC while limiting the risk of heart toxicity. FDG PET will be used to simultaneously assess both cardiac inflammation and tumour response. Quantitative DCE-CT will also be used to measure ventilation and perfusion changes in the normal lung and tumour after radiotherapy, providing image data that can comprehensively assess both tumour response and potential toxicity in both the heart and lungs. Such information is crucial in understanding the disease and its response to treatment. This data will also aid in the design of radiation techniques that spare the heart in other patients with any thoracic malignancies, including breast cancer, lymphoma, and esophageal cancer.
The investigators propose a longitudinal imaging pilot study composed of 20 Stage I-III NSCLC patients before, and six weeks after standard radiotherapy using a hybrid 3T-PET/MRI system (Biograph mMR, Siemens Healthcare) and a GE Revolution 256-slice CT scanner. The imaging protocol is designed to detect acute changes in myocardial perfusion, inflammation, edema, left ventricular ejection fraction, normal lung and tumour perfusion, and tumour metabolism. During each imaging session, patients will receive an 18F-FDG PET scan to image macrophage-related inflammation and tumour metabolism, MRI to identify edema, mature fibrosis or scar, and Dynamic contrast enhanced CT (DCE-CT) imaging to image perfusion and (LVEF). All images will be fused and rendered with radiation treatment planning dose distributions. Parameters such as Standard Uptake Value (SUV) will be used to compare PET scans, while heart volume and presence of Gadolinium enhancement will be used to compare MRI scans. Blood flow, blood volume, and permeability will be used to compare CT scans. Blood tests including Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin at each timepoint will also be performed to detect cardiac inflammation. Comparisons between Stage I/II and Stage III patients will allow us to determine whether our metrics for heart changes is radiation related. Relative differences from the six-week time point to baseline will be correlated with the radiation dose distribution to attempt to define a dose-response relationship between radiation dose and cardiac toxicity.
Ultimately, the sample size was based upon practical considerations and that 20 NSCLC patients (10 Stage I/II and 10 Stage III) could be accrued relatively easily from new patient clinics, while sufficiently providing enough evidence to validate the imaging techniques to be used as a non-invasive measure for future clinical trials aimed at reducing or mitigating radiation-induced cardiac toxicity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stage I/II NSCLC patients receiving standard stereotactic body radiation therapy and Stage III patients receiving Standard platinum-based chemoradiotherapy will receive PET/MRI, DCE-CT, ECG/EKG, and bloodwork before and six weeks post treatment.
Radiation: Standard platinum-based chemoradiotherapy
Stage III patients: Standard platinum-based chemotherapy, total radiation dose 60 Gy in 30 fractions. Stage I/II patients: Standard radiotherapy, total radiation dose of 54 Gy in 3 fractions (peripheral), 55 Gy in 5 fractions (near chest wall), or 60 Gy in 8 fractions (central).
Detection of Imaging Biomarkers of acute cardiac inflammation
FDG-PET imaging to detect increase in cardiac inflammation compared to baseline with corresponding blood markers (Erythrocyte Sedimentation Rate (ESR), high sensitivity C-reactive protein, and troponin levels in blood (inflammation)).
Time frame: 6 weeks
Detection of Imaging Biomarkers of acute cardiac perfusion changes
DCE-CT imaging to detect changes in acute cardiac perfusion changes compared to baseline.
Time frame: 6 weeks
Detection of Imaging Biomarkers of acute changes in Left-ventricular ejection fraction (LVEF)
Contrast-enhanced CT imaging to detect acute changes in LVEF compared to baseline.
Time frame: 6 weeks
Detection of cardiac fibrosis
Gadolinium Enhanced MR imaging to detect cardiac fibrosis compared to baseline
Time frame: 6 weeks
Tumour Response (metabolism)
FDG-PET imaging to detect tumour metabolism changes compared to baseline.
Time frame: 6 weeks
Tumour Response (perfusion)
DCE-CT imaging to detect changes in tumour perfusion compared to baseline
Time frame: 6 weeks
Acute Changes in Lung Ventilation
4D-CT imaging to detect changes in lung ventilation compared to baseline
Time frame: 6 weeks
Acute Changes in Lung Perfusion
DCE-CT imaging to detect changes in lung perfusion compared to baseline
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Mar 2019, 13 months after the start.
Of 356 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 13 months is below that.
Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's →