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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03523494
• Other study ID #: chhwang9
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2019
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Development of lympho-proliferation reticulation quantification using CT.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• CT
• Lymphedema
• Secondary Lymphedema

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan,

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International Society of Lymphology stage	stage Ia, Ib, IIa, IIb, IIIa, and IIIb	1 week
Other	lymphascintigraphy stage	Normal: 1; delayed flow, but visible axillary lymph or inguinal lymph node: 2; , invisible axillary lymph or inguinal lymph node: 3: visible dermal backflow: 4	1 week
Other	circumference between normal and involved limbs	5cm above and below mid-antecubital or mid-popliteal fossa	1 week
Primary	Reticulation Ratio from Computerized Tomography	calculated value of reticulation	1 week
Secondary	Multi-frequency bio-electric impedance analysis	comparative ratio using 1KHz	1 week