Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography

Completed

• Conditions: Lymphedema; Secondary Lymphedema; CT

• Registration Number: NCT03523494
• Lead Sponsor: Ulsan University Hospital

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

Exclusion Criteria

• Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda)
• Lymph edema simultaneously involving both limbs
• Patients who undertook implantation of electrical devices such as cardic pacemakers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reticulation Ratio from Computerized Tomography	1 week	calculated value of reticulation

Secondary Outcome Measures

Name	Time	Method
Multi-frequency bio-electric impedance analysis	1 week	comparative ratio using 1KHz

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan,, Korea, Republic of