None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate whether endoscopic examination of the chest is useful for identifying disease sites in non-small cell lung cancer, which are not visible on standard care PET scans. Who is it for? You may be eligible to participate in this trial if you are aged 18 to 80 years, with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases (stage III A-B based on mediastinal nodal involvement). Study details All participants enrolled in this trial will receive the endoscopic staging procedure in addition to the standard care PET scan. The endoscopic staging procedure will involve an endoscopy procedure (performed under deep intravenous sedation) where examination of all lymph nodes in the mediastinum will be performed, and sampling of any identified nodes perfomred. The procedure is required on the basis of your PET findings. The procedure lasts 20-30 minutes and is usually performed as a day procedure. The results of the staging procedure will be used to guide planning the dose of radiotherapy received. Researchers will compare the results obtained from the endoscopic staging procedure with the results from the PET scan to evaluate whether the staging procedure may be able to detect additional cancer sites which are not detected on the PET scan. If so, this will improve targeting of radiation treatment in non-small cell lung cancer patients with mediastinal metastases by ensuring that all disease sites receive adequate radiation doses, thereby minimizing the risk of under-treatment and disease recurrence.
Interventions
Exposure: systematic staging of mediastinal lymph nodes via endoscopic staging.
Staging will be performed by experienced respiratory physicians using a linear endobrnchial ultrasound videobronchoscope.
Patients will undergo standard FDG-PET prior to staging procedure. Staging procedure will be approximately 20-30 minutes duration, and be completed prior to radiation planning.
The staging procedure is an endoscopic procedure performed under deep sedation. Linear Endobronchial Ultrasound will b
Exposure: systematic staging of mediastinal lymph nodes via endoscopic staging. Staging will be performed by experienced respiratory physicians using a linear endobrnchial ultrasound videobronchoscope. Patients will undergo standard FDG-PET prior to staging procedure. Staging procedure will be approximately 20-30 minutes duration, and be completed prior to radiation planning. The staging procedure is an endoscopic procedure performed under deep sedation. Linear Endobronchial Ultrasound will be used to visualize all mediastinal LN stations (2R, 4R, 7, 4L, 2L) and to allow EBUS-TBNA sampling of any LN exceeding 6mm in short axis dimension) Results from the staging procedure will be made available to Radiation Oncology team to allow optimal treatment planning The treatment plan used in clinical care of patients will incorporate both PET and EBUS findings. Theoretical planning will be performed to determine dosimetry in the event that only PET findings were available, to allow some estimation of the dosimetric impact (both dose to tumour, and toxicity risks) that detection of PET-occult disease by EBUS will have on patient outcomes
Sponsors
Daniel Steinfort
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with known/suspected non-small cell lung cancer (NSCLC) and suspected/known mediastinal metastases. (stage III A-B based on mediastinal nodal involvement)
Exclusion criteria
i. medical co-morbidities preclude bronchoscopy ii. medical co-morbidities or known pathologic extent of disease precludes consideration of radiotherapy iii. age <18 or >80 years
Outcome results
None listed