The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation - Human Study.

NCT04230317 | Unknown

• 1 other identifier: NRF-2018R1D1A1B07046024
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in medical imaging technology have made it possible to detect patients with small-sized lung lesions early. Generally, invasive methods such as PCNA were used to diagnose peripheral lung nodule. However, Radial probe endobronchial ultrasonography (RP-EBUS) is widely used in the histological diagnosis of peripheral lung nodule in recent years. In order to carry out RP-EBUS, it is necessary to know the path to the lesion to access it. Conventionally, the path to the peripheral lung nodule is identified by the drawing, but recently, the path is reviewed by the virtual bronchoscopy navigation (VBN) which is reconstructed 3-dimension image using the CT data. Currently, VBN is driven by using raw data acquired using standard thin sectioned chest CT protocol, but the problem is that additional doses of radiation are exposed to patients who have initially discovered lung lesions using low dose CT. Therefore, we conduct a randomized controlled trial to verify the suitability of VBN using the raw data acquired by low dose CT.

Conditions

Bronchoscopy

Keywords

Computer simulation, Multislice computed tomography

Outcome Measures

Primary Outcomes (1)

• Concordance rate of VBN simulation results

  Concordance rate comparing the VBN result driven based on raw data acquired with low dose CTs taken with three different protocols compared to the VBN result driven based on raw data obtained with standard protocol CT.

  From CT scan to VBN drive (an average of 1 week)

Study Arms (2)

Low dose chest CT simulation

EXPERIMENTAL

VBN result driven using raw data acquired with low dose CTs taken with three different protocols

Diagnostic Test: Chest CT

Standard protocol chest CT simulation

ACTIVE COMPARATOR

VBN result driven using raw data acquired with standard protocol CT

Diagnostic Test: Chest CT

Interventions

Chest CT DIAGNOSTIC_TEST

Low dose CT taken with three different protocols

Low dose chest CT simulation; Standard protocol chest CT simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Competent to give informed consent
• Patients requiring a pathological diagnosis of pulmonary nodules using RP-EBUS.
• Patients who need chest CT before RP-EBUS.

You may not qualify if:

• Pregnancy
• Patients who could not receive chest CT
• Inability to obtain informed consent
• Patients unable to perform RP-EBUS

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Related Publications (1)

• Kim I, Lee G, Eom JS, Ahn HY, Kim A. Feasibility of low dose chest CT for virtual bronchoscopy navigation in a porcine model. Respir Res. 2019 Jul 8;20(1):142. doi: 10.1186/s12931-019-1109-8.

  PMID: 31286968 BACKGROUND

Study Officials

• Jung Seop Eom

  Pusan university hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 18, 2020
• Study Start: January 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)