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

The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation in Human Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Bronchoscopy
• Intervention / Treatment: Diagnostic test: Chest CT

Detailed Description

The standard thin sectioned protocol CT consists of scout, enhanced and non-enhanced image. Therefore, in this study, non-enhanced protocol CT was taken with low dose protocols with three different radiation doses to acquire raw data and drive VBN, and compared with the VBN result driven with raw data obtained with standard protocol. The primary endpoint of this study is to verify the consistency and accuracy of the VBN results driven by the raw data obtained with the low dose protocol CT.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

1. Inclusion Criteria:

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

2. Exclusion Criteria:

   1. Pregnancy
   2. Patients who could not receive chest CT
   3. Inability to obtain informed consent
   4. Patients unable to perform RP-EBUS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose chest CT simulation; VBN result driven using raw data acquired with low dose CTs taken with three different protocols	Diagnostic test: Chest CT; Low dose CT taken with three different protocols
Active Comparator: Standard protocol chest CT simulation; VBN result driven using raw data acquired with standard protocol CT	Diagnostic test: Chest CT; Low dose CT taken with three different protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Study Chair: Jung Seop Eom, Pusan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Computer simulation, Multislice computed tomography
• Other Study ID Numbers: NRF-2018R1D1A1B07046024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No