- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523494
Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography
Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ulsan,, Korea, Republic of, 682-714
- Ulsan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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