1. To identify and quantify the structural airway wall layers with OCT and rEBUS and correlate this to histology and HRCT2. To identify and quantify the effect of bronchial thermoplasty on the airway wall layers by OCT and rEBUS and correlate this…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification of airway wall layers with OCT by direct comparison to
histology.
Secondary outcome
1. Identification of airway wall layers with rEBUS by direct comparison to
histology.
2. Quantification of airway wall layers with OCT by measurement of detected:
thickness of the different airway wall layers (epithelium, submucosa and airway
smooth muscle cell layer) in mm, airway wall area mm2 , lumen diameter (mm),
lumen area in (mm2) and relate this to histology and HR-CT measurements.
3. Quantification of airway wall layers with rEBUS by measurement of detected:
thickness of the different airway wall layers (epithelium, submucosa and airway
smooth muscle cell layer) in mm, airway wall area mm2 , lumen diameter (mm),
lumen area in (mm2) and relate this to histology and HR-CT measurements.
4. To compare in vivo OCT-identified and quantified airway wall layers with ex
vivo OCT imaging measurements.
5. To compare in vivo rEBUS identified and quantified airway wall layers with
ex vivo rEBUS imaging measurements.
6. Identification and quantification of OCT detected Bronchial Thermoplasty
induced changes in airway wall layers ex vivo and relate this to airway
histology.
7. Identification and quantification of rEBUS detected Bronchial Thermoplasty
induced changes in airway wall layers ex vivo and relate this to histology.
Background summary
The current imaging techniques available for assessing airway wall
layers/airway remodelling have limitations. Optical coherence tomography (OCT)
is a high resolution optical imaging technique which is able to generate high
definition in vivo images of the different layers of the airway wall. Next to
OCT, radial endobronchial ultrasound (rEBUS) is also enable to assess the
different airway wall layers. For anatomical interpretation purposes, OCT/rEBUS
images need to be correlated with the pathology standard histology and imaging
standard High-Resolution Computed Tomography (HRCT). Bronchial Thermoplasty
(BT) is a novel treatment for severe asthma that aims to target increased
airway smooth muscle mass and related airway remodelling. Potentially, OCT
and/or rEBUS are ideal screening (increased airway smooth muscle mass present?)
and monitoring (decreased airway smooth muscle mass after BT?) tools.
Study objective
1. To identify and quantify the structural airway wall layers with OCT and
rEBUS and correlate this to histology and HRCT
2. To identify and quantify the effect of bronchial thermoplasty on the airway
wall layers by OCT and rEBUS and correlate this to histology and HRCT
Study design
This is an investigator-initiated observational study. 5 patients with a strong
suspicion of a peripheral lung tumor based on positron emission tomography-
computed tomography (PET-CT) and candidate for surgical resection of the tumor
will be enrolled. At the end of the standard diagnostic endoscopic work up,
additional in vivo OCT/rEBUS imaging of 3 airways will be performed. After
lobectomy resected pulmonary specimen will be used for ex vivo measurements
with OCT, rEBUS and HRCT. 2 airways will be treated ex vivo with bronchial
thermoplasty after which OCT and rEBUS will be repeated. At last the tissue
will be obtained and processed for histology.
Study burden and risks
The benefit of study participation is that the results of this study may be
important for other patients with a variety of pulmonary diseases. OCT is a
promising safe, minimally-invasive imaging technique that in conjunction with
conventional bronchoscopy can provide real time, high resolution imaging of the
airway wall. OCT could be useful as a screening and monitoring tool to select
asthma patients for BT treatment. Possibly in oncology OCT might have clinical
application (extent of tumor invasion in the airway wall).
There is little burden related to study participation: at the end of the
standard bronchoscopy during lung cancer work-up, additional OCT/ rEBUS
imaging will be obtained. Estimated prolonged endoscopy time for combined OCT
and rEBUS imaging is 15 minutes. The patient will not notice anything due to
the use of propofol sedation. Adverse events are not expected. Currently in the
Academic Medical Center Amsterdam (AMC), we are performing OCT and rEBUS as
part of the TASMA study (study number: NL45394.018.13). Based on our own
experiences, OCT/ rEBUS is a safe, easy to perform and only little
time-consuming procedure without adverse events.
In this study proposal, after the scheduled resection of the lung cancer, the
resected lung will be worked up as usual by the pathologist. The part of the
lung which would normally be wasted, will be used for this study to correlate
OCT/rEBUS imaging to histology and HR-CT ex vivo. The diagnostic (endoscopy),
therapeutic (lobectomy) process nor pathological evaluation will not be
affected by this study. In conclusion we believe that the burden and risks
associated with participation are neglectable.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Strong suspicion or tissue proven NSCLC staged cT1-3N0-1M0 based on PET-CT and need for standard diagnostic endoscopic workup
- Candidate for surgical resection of the lung tumor (lobectomy/pneumonectomy)
Exclusion criteria
- Inability to provide informed consent.
- Inability to comply with the study protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51605.018.14 |