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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04230317
Enrollment
180
Registered
2020-01-18
Start date
2020-01-20
Completion date
2021-12-30
Last updated
2020-07-20

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

Conditions

Bronchoscopy

Keywords

Computer simulation, Multislice computed tomography

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.

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.

Interventions

DIAGNOSTIC_TESTChest CT

Low dose CT taken with three different protocols

Sponsors

Pusan National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Concordance rate of VBN simulation resultsFrom CT scan to VBN drive (an average of 1 week)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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026