Viewing Study NCT03523494


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Study NCT ID: NCT03523494
Status: COMPLETED
Last Update Posted: 2019-03-08
First Post: 2018-04-17
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography
Sponsor: Ulsan University Hospital
Organization:

Study Overview

Official Title: Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography.
Status: COMPLETED
Status Verified Date: 2019-03
Last Known Status: None
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: Development of lympho-proliferation reticulation quantification using CT.
Detailed Description: It is known that fibrosis of the subcutaneous soft tissue progresses over time in the lymph edema, and this change progresses to reticulation pattern.

Authors will develop a digital subtraction technique for the extraction of lympho-proliferative reticulation using the Housfield unit of non-reticulation structure (bones, muscles, tendons, vessels, nerves) in the axial image of CT.

Based on the medical records, authors will develop an early diagnosing tool by checking the correlation of the values derived the new technique with circumference, multi-frequency bio-electric impedance analysis, ISO sub-stage, and lymphascintigraphy, and qualify the cut-off values showing high sensitivity and specificity through the receiver operating characteristics (ROC) curve analyses.

Study Oversight

Has Oversight DMC: True
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?: