Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University
About this trial
The objective of this study is to explore the role of ultrasonography (non-invasive imaging device) in the diagnosis of subcutaneous nodules (mass/bumb underneath the skin).
Patients who presented with subcutaneous nodules and was indicated for diagnostic skin biopsies were recruited. Prior to skin biopsies (not part of the study's intervention), ultrasonography(intervention) was used to examine the characteristics of the nodules. The ultrasonographic findings are then compared to the pathological results to explore the role of ultrasonography in differentiating each disease or group of diseases that presented with skin nodules.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older who presented with subcutaneous nodules
Indicated for pathological examination for disease diagnosis.
Patients with subcutaneous nodules located in areas where a tissue sample can be taken down to the fat layer.
Patients who agree to participate in the project by signing the consent form.
Disqualifiers
Presence of inflammation or other tumors that can mimic panniculitis, such as painful lipomas, cellulitis, and leg interstitial edema.
Patients with diseases that significantly alter the structure of the skin or subcutaneous tissue, such as scleroderma or severe edema.
A history of previous treatments in the area of the subcutaneous mass (e.g., surgery, radiation therapy, or high-dose steroid treatment) that may interfere with ultrasound results.
Patients with lesions on the head or mucous membranes of the body.
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous ultrasound
Diagnostic testThe ultrasonographic characteristics of the subcutaneous nodules were evaluated using an ultrasound machine (Venue Go™, wide-band linear array ultrasound probe (hockey stick shape), frequency range between 6.7 MHz and 18.0 MHz, from GE HealthCare Illinois, United States). The procedure for capturing images at the location of the lesion of interest is as follows: * Brightness mode (B-mode): Record at least 4 images using a depth of 2 cm. * Color Doppler mode: Record images along the vertical axis (1 image) and along the horizontal axis (1 image). The two axes mentioned above must be perpendicular to each other. * Video recording: Capture at least 10 seconds of video in both Brightness mode and Color Doppler mode.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Transcutaneous ultrasonographyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subcutaneous echogenicity
In this study, we aim to explore the relationship between ultrasonographic characteristics of subcutaneous nodules(A) and the pathological findings from biopsy samples(B). (A) The primary outcome measure is the subcutaneous echogenicity A1) hyper-echoic, A2) hypo-echoic, A3) iso-echoic. (B) Pathological results are graded as either B1) Infectious, B2) Non-infectious
Time frame
Through study completion averaging 2 yearsSecondary outcomes
1
Subcutaneous fat septum thickness
In this study, we aim to explore the relationship between ultrasonographic characteristics of subcutaneous nodules (A) and the pathological findings from biopsy samples (B). (A) The secondary outcome measure is the subcutaneous fat septum thickness A1) more than or equal to 1mm : septal thickening present, A2) less than 1mm : septal thickening absent (B) Pathological results are graded as either B1) Infectious, B2) Non-infectious
Time frame
Through study completion averaging 2 yearsSponsors and contacts
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Source ClinicalTrials.gov