RecruitingNot ApplicableNCT06838988

Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules


Sponsor

Mahidol University

Enrollment

100 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria9

  • 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.
  • Pregnant or breastfeeding patients.
  • Presence of wounds or open sores in the area to be examined with ultrasound.
  • A history of coagulopathy (blood clotting disorders).
  • Patients with metal implants in the area of interest that may interfere with ultrasound imaging.
  • Participants who refuse or withdraw from the study.

Interventions

DIAGNOSTIC_TESTTranscutaneous ultrasound

The 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.


Locations(1)

Ramathibodi Hospital

Bangkok, Ratchathewi, Thailand

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NCT06838988


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