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

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ClinicalTrials.gov Identifier: NCT03523494
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Ho Hwang, Ulsan University Hospital

Brief Summary:
Development of lympho-proliferation reticulation quantification using CT.

Condition or disease
Lymphedema Secondary Lymphedema 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.


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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Normal limb
Normal
Abnormal limb
Lymph Edema



Primary Outcome Measures :
  1. Reticulation Ratio from Computerized Tomography [ Time Frame: 1 week ]
    calculated value of reticulation


Secondary Outcome Measures :
  1. Multi-frequency bio-electric impedance analysis [ Time Frame: 1 week ]
    comparative ratio using 1KHz


Other Outcome Measures:
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523494


Locations
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Korea, Republic of
Ulsan University Hospital
Ulsan,, Korea, Republic of, 682-714
Sponsors and Collaborators
Ulsan University Hospital
Investigators
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Study Director: Chang Ho Hwang, M.D., Ph.D. Ulsan University Hospital

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Responsible Party: Chang Ho Hwang, Associate professor, PhD and MD, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT03523494     History of Changes
Other Study ID Numbers: chhwang9
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases