HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study

Lungcancer Clinical Trial

— i-scan  

Official title:

A Multicenter Study Evaluating the Diagnostic Value for Vascular Abnormalities of High Definition Bronchoscopy When Combined With I-scan Imaging Technology Compared to High Defintion Bronchoscopy Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285426
• Other study ID #: NL5012109114
• Status: Completed
• First received: October 27, 2014
• Last updated: April 11, 2018
• Start date: October 20, 2014
• Est. completion date: June 5, 2017

Study information

• Verified date: April 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways and pivotal for the diagnosis and staging of lung cancer. Further technological improvements have resulted in high definition (HD+) images and advanced image enhancement technique (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination with i-scan technology is superior to HD+WL (white light) for detecting endobronchial vascular changes. In this study we aim to correlate these vascular changes to histology and hypothesize that these vascular changes are related to (pre-) malignant changes and that the addition of i-scan is superior to HD+ WL.

Description:

Patients will undergo a bronchoscopy with Pentax EB1990i HD-bronchoscope in combination with Pentax EPKi series videoprocessor investigating the entire bronchial tree. Bronchoscopy will be performed by an experienced chest physician under local anaesthesia use and type of sedation following local protocol. Bronchoscopy will be performed in a standardized order using three different imaging modes. The order of the different modes will be randomized to avoid induced scope and / or cough lesion bias. High definition digital videos will be made from all procedures without in screen patient identification, but using a study code. The three imaging modes used in this study are: HD+, HD+ surface enhancement (SE, i-scan1) and HD+ surface enhancement and tone enhancement (TE-c, i-scan2).

When sites with abnormal or suspicious vascular patterns are detected the investigator grade these findings using a visual classification scale [adapted from Herth JTO 2009 & Zaric Med Oncol 2013] and change to a regular bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control. Finally any other indicated procedures will be performed at the discretion of the local investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 5, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with indication for diagnostic bronchoscopy for suspected or proven lung cancer.

• ASA physical status 1-3.

• Age 18 years or older.

• Signed and dated patient informed consent.

Exclusion Criteria:

• Bleeding disorders.

• Indication for use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines or clopidrogel).

• Known allergy for lidocaine.

• Known pulmonary hypertension.

• Recent and/or uncontrolled cardiac disease.

• Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis for any reason).

• ASA classification greater than or equal to 4.

• Pregnancy.

• Inability to consent.

Related Conditions & MeSH terms

• Lung Neoplasms
• Lungcancer

Intervention

Device:
• Pentax EB-1990i HD-bronchoscope guided biopsy
3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree. When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality [visual scale adapted from Herth 2009 and Zaric 2013] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.

Locations

Country	Name	City	State
Italy	Ospedale Umberto I, Via Dante Alighieri n.1	Ravenna	RA
Netherlands	RadboudUMC	Nijmegen	Gelderland
Russian Federation	St-Petersburg Research Institute of TB and Thoracic Surgery	Saint-Petersburg
Spain	Hospital Universitario Santa Lucia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Countries where clinical trial is conducted

Italy,  Netherlands,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive value of HD+ i-scan bronchoscopy for detecting (pre-) malignant lesions	Determing the positive predictive value of HD+ i-scan bronchoscopy for vascular pattern detection .	7 days
Secondary	correlation between endobronchial vascular patterns and histology	relate grading of detected vascular abnormalities with histology outcome of biopsies	7 days
Secondary	interobserver variability for detecting vascular abnormalities	compare bronchoscopist reported outcome to central review of obtained videos to determine interobserver variability	3 - 12 months
Secondary	impact of HD-bronchoscopy on clinical decision	interview based evaluation to investigate whether the use of of i-scan technology and or the outcome of study-detected vascular sites changed the clinical approach or follow-up plan	1-56 days