Advanced imaging of the airway wall by OCT and rEBUS compared to the pathology standard histology and imaging standard HRCT

Advanced imaging of the airway wall by OCT and rEBUS compared to the pathology standard histology and imaging standard HRCT - Airway wall imaging by OCT and rEBUS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41953

Enrollment

Registered

2015-01-06

Start date

2015-04-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway wall diseases

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Inability to provide informed consent. - Inability to comply with the study protocol

Design outcomes

Primary

Measure	Time frame
Identification of airway wall layers with OCT by direct comparison to histology.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results