None listed
Conditions
Brief summary
The primary purpose of this trial is to examine the detection rate of lesions using narrow band imaging (NBI bronchoscopy) with a computed tomography (CT) scan, in comparison to the standard white light bronchoscopy in head and neck cancer patients who completed treatment 3-5 years previously. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have completed curative treatment for a head or neck cancer in the previous 3-5 years. Study details All participants will receive a bronchoscopy, CT scan of chest and spirometry . Bronchoscopy is a procedure done under a light sedative where we look at the bronchial tubes as well as the upper airway and voice box. In this we can use a normal "white" light as well as a "blue" light. The Blue light potentially helps to find the earliest changes in the upper airway and bronchial tubes. Where it looks abnormal we take a small sample, a biopsy. Any biopsied tissue will then be analysed in a laboratory to examine whether it contains abnormal/cancerous tissue. Researchers will compare the rate of lesion detection using both types of imaging.Also each patient will have a CT (CAT) scan of the chest in the Radiology (Xray) department to look for any supsicious areas there, as is usually done by ENT surgeons at this timepoint. We will use a computer to assist in the interpretation of the CT scan. All patients will have a simple breathing test (Spirometry) in the Lung function ldepartment which requires 2 or 3 deep breaths into a tube to record the lung capacity. This will give us information about the way lung capacity may be related to the risk of developing small additional cancers. It is hoped that the findings from this trial will provide information on whether NBI bronchoscopy may be beneficial in the detection of airway lesions in previous head and neck cancer patients, in whom these tumours are relatively common.
Interventions
The first is a breathing test done in the Lung Function lab. This should take 20 minutes and you may well have had this before. This is to see whether there is any other lung conditions which can make early cancers more likely.
The second is the camera into the throat and lungs ( Bronchoscopy). When we do the camera examination you will be given medication to make you sleepy to make the procedure as comfortable as possible. This is a normal practice with many such tests. This is done as an outp
The first is a breathing test done in the Lung Function lab. This should take 20 minutes and you may well have had this before. This is to see whether there is any other lung conditions which can make early cancers more likely. The second is the camera into the throat and lungs ( Bronchoscopy). When we do the camera examination you will be given medication to make you sleepy to make the procedure as comfortable as possible. This is a normal practice with many such tests. This is done as an outpatient day case procedure. The medication is given through a small needle (cannula) and a numbing medicine is sprayed in the back of the throat. The doctor first of all looks in detail at the throat region with the assistance of the ENT surgeon, then passes the scope down through the vocal cords (voice box) into the lung (air passages). This is a standard procedure. In the first part of the procedure just a standard light will be used and the appearance recorded. Then the blue light will be used to look at the same regions. This blue light has a wavelength of 450 nm- it is not a laser and does not affect the bronchial tubes in any way. Any areas which require a sample to be taken will be noted and samples taken using a biopsy (sample) forcep. This is a standard method for obtaining material to confirm whether there is anything significant which may require treatment. Biopsies of the throat region will be done with the ENT surgeon, and biopsy of the air passages by the Respiratory specialist doing the procedure. One additional biopsy of normal appearing airway lining will be taken for comparison. This is a tiny amount of material (only 1 or 2 millimeters across). This is so we can check that we are not missing significant changes elsewhere in the air passages.In the procedure approximately 10 minutes of white light is used, then approximately 10 minutes NBI blue light is used, dependent on the number of lesions and biopsies required. Patients go home the same day. Biopsies will be followed up at an outpatient clinic the following week. Any treatment which is required will be discussed between yourself and your doctor as is the usual practice following a biopsy. You will be therefore be participating in a cross-over study. In a cross-over study the patients have one method of investigation followed by a different method and the two are compared. In this study the first method is the white light and the second method is the blue light. We want to compare which light gives the best results in terms of finding early cancers. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions. This is done by reporting of the biopsy results by the pathologist without knowledge of which colour light was in use when the abnormality prompting the biopsy was found. The third procedure is a CT (CAT) scan of the chest. This is also done as a day case It takes only 5 minutes and patients lie on the examination table and the scan is taken as they hold a single deep breath. Results of this will also be discussed at the time of the other appointment as above. If the camera test and CT are negative for any abnormal areas then just normal follow-up will continue with the ENT department. If there are abnormalities of the camera depending on biopsy there may be a need for a follow-up bronchoscopy in 3-6 months time; if there is a cancer there steps will be initiated immediately to organise treatment for that. Similarly if there are abnormalities on the CT chest these may require follow-up scan in 3-6 months, or a biopsy in those few cases where there is an obvious abnormality requiring immediate attention. The study will run for two years however only these initial 3 tests are done for the research study. Follow-up tests would only be done in the event of abnormalities as mentioned above. We would follow the results of any additional biopsies or treatments over the two years of the study. Those treatments would be directed by your own doctors who already follow your case up, or the Respiratory specialist who did the camera test.
Sponsors
Royal Brisbane and Womens Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 3-5 years post completion of curative treatment of Head and Neck Cancer ( either surgery or chemoradiation.)
Exclusion criteria
Severe COPD or active coronary artery disease making bronchoscopy unsafe
Outcome results
None listed