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Completed

NCT Number: NCT03523494

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

Development of lympho-proliferation reticulation quantification using CT.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulsan University Hospital

Ulsan, 682-714, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reticulation Ratio from Computerized Tomography

    Time frame: 1 week

    calculated value of reticulation

Secondary outcomes

  1. Multi-frequency bio-electric impedance analysis

    Time frame: 1 week

    comparative ratio using 1KHz

Other outcomes

  1. International Society of Lymphology stage

    Time frame: 1 week

    stage Ia, Ib, IIa, IIb, IIIa, and IIIb

  2. lymphascintigraphy stage

    Time frame: 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

  3. circumference between normal and involved limbs

    Time frame: 1 week

    5cm above and below mid-antecubital or mid-popliteal fossa

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 14, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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