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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03523494

Enrollment

Registered

2018-05-14

Start date

2017-01-01

Completion date

2018-03-30

Last updated

2019-03-08

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

Conditions

CT, Lymphedema, Secondary Lymphedema

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reticulation Ratio from Computerized Tomography	1 week	calculated value of reticulation

Secondary

Measure	Time frame	Description
Multi-frequency bio-electric impedance analysis	1 week	comparative ratio using 1KHz

Other

Measure	Time frame	Description
International Society of Lymphology stage	1 week	stage Ia, Ib, IIa, IIb, IIIa, and IIIb
lymphascintigraphy stage	1 week	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
circumference between normal and involved limbs	1 week	5cm above and below mid-antecubital or mid-popliteal fossa

Countries

South Korea

Outcome results