Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04230317
Status:
UNKNOWN
Last Update Posted:
2020-07-20
First Post:
2020-01-05
Brief Title:
The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation - Human Study
Sponsor:
Pusan National University Hospital
Organization:
Pusan National University Hospital
Study Overview
Official Title:
The Feasibility of Low Dose Chest CT for Virtual Bronchoscopy Navigation in Human Patients
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None