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

Pusan National University

Status: Unknown

Conditions: Bronchoscopy

Treatments: Diagnostic Test: Chest CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04230317

NRF-2018R1D1A1B07046024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Low dose chest CT simulation

Experimental group

Description:

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

Treatment:

Diagnostic Test: Chest CT

Standard protocol chest CT simulation

Active Comparator group

Description:

VBN result driven using raw data acquired with standard protocol CT

Treatment:

Diagnostic Test: Chest CT