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

March 6, 2019 updated by: Chang Ho Hwang, Ulsan University Hospital

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

Development of lympho-proliferation reticulation quantification using CT.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal limb
Normal
Abnormal limb
Lymph Edema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reticulation Ratio from Computerized Tomography
Time Frame: 1 week
calculated value of reticulation
1 week

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chhwang9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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