Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules

NCT06838988 | Recruiting

• 1 other identifier: MURA2025/83
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nodules; Ultrasonography; Panniculitis

Keywords

Nodules; Ultrasonography; panniculitis

Outcome Measures

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

  Through study completion averaging 2 years

Secondary Outcomes (1)

• Subcutaneous fat septum thickness

  Through study completion averaging 2 years

Study Arms (1)

Transcutaneous ultrasonography

EXPERIMENTAL

This is a single group study with one intervention arm where every subjects received ultrasonographic evaluations of their skin lesions (subcutaneous nodules)

Diagnostic Test: Transcutaneous ultrasound

Interventions

Transcutaneous ultrasound DIAGNOSTIC_TEST

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.

Transcutaneous ultrasonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Ramathibodi Hospital

Bangkok, Ratchathewi, 10400, Thailand

RECRUITING

Related Publications (14)

• Kang BS, Choi SH, Cha HJ, Jung YK, Lee JH, Jeong AK, Shin SH, Kwon WJ. Subcutaneous panniculitis-like T-cell lymphoma: US and CT findings in three patients. Skeletal Radiol. 2007 Jun;36 Suppl 1:S67-71. doi: 10.1007/s00256-006-0173-6. Epub 2006 Aug 15.

  PMID: 16909278 BACKGROUND

• Nazzaro G, Maronese CA, Passoni E. Ultrasonographic diagnosis of erythema nodosum. Skin Res Technol. 2022 Mar;28(2):361-364. doi: 10.1111/srt.13112. Epub 2021 Nov 23. No abstract available.

  PMID: 34813122 BACKGROUND

• Delgado-Jimenez Y, Fraga J, Garcia-Diez A. Infective panniculitis. Dermatol Clin. 2008 Oct;26(4):471-80, vi. doi: 10.1016/j.det.2008.05.005.

  PMID: 18793979 BACKGROUND

• Gaviria JL, Ortega VG, Gaona J, Motta A, Medina Barragan OJ. Unusual Dermatological Manifestations of Gout: Review of Literature and a Case Report. Plast Reconstr Surg Glob Open. 2015 Aug 10;3(7):e445. doi: 10.1097/GOX.0000000000000420. eCollection 2015 Jul.

  PMID: 26301134 BACKGROUND

• Maldonado Cid P, Rubio Flores C, Prats Caelles I, Leis Dosil VM, Alfageme Roldan F, Richi Alberti P, Santonja Garriga C, Diaz Diaz RM. High-frequency ultrasound features in a case of gouty panniculitis. Dermatol Online J. 2017 Jun 15;23(6):13030/qt33j2z14m.

  PMID: 28633741 BACKGROUND

• Romani J, Giavedoni P, Roe E, Vidal D, Luelmo J, Wortsman X. Inter- and Intra-rater Agreement of Dermatologic Ultrasound for the Diagnosis of Lobular and Septal Panniculitis. J Ultrasound Med. 2020 Jan;39(1):107-112. doi: 10.1002/jum.15080. Epub 2019 Jun 27.

  PMID: 31245860 BACKGROUND

• Catalano O, Wortsman X. Dermatology Ultrasound. Imaging Technique, Tips and Tricks, High-Resolution Anatomy. Ultrasound Q. 2020 Dec;36(4):321-327. doi: 10.1097/RUQ.0000000000000520.

  PMID: 33298770 BACKGROUND

• Wortsman X, Alfageme F, Roustan G, Arias-Santiago S, Martorell A, Catalano O, Scotto di Santolo M, Zarchi K, Bouer M, Gonzalez C, Bard R, Mandava A, Gaitini D. Guidelines for Performing Dermatologic Ultrasound Examinations by the DERMUS Group. J Ultrasound Med. 2016 Mar;35(3):577-80. doi: 10.7863/ultra.15.06046. Epub 2016 Feb 17.

  PMID: 26887446 BACKGROUND

• Nessi R, Betti R, Bencini PL, Crosti C, Blanc M, Uslenghi C. Ultrasonography of nodular and infiltrative lesions of the skin and subcutaneous tissues. J Clin Ultrasound. 1990 Feb;18(2):103-9. doi: 10.1002/jcu.1870180207.

  PMID: 2156901 BACKGROUND

• Mandava A, Ravuri PR, Konathan R. High-resolution ultrasound imaging of cutaneous lesions. Indian J Radiol Imaging. 2013 Jul;23(3):269-77. doi: 10.4103/0971-3026.120272.

  PMID: 24347861 BACKGROUND

• Gropper CA, Stiller MJ, Shupack JL, Driller J, Rorke M, Lizzi F. Diagnostic high-resolution ultrasound in dermatology. Int J Dermatol. 1993 Apr;32(4):243-50. doi: 10.1111/j.1365-4362.1993.tb04261.x. No abstract available.

  PMID: 8486453 BACKGROUND

• Requena L. Normal subcutaneous fat, necrosis of adipocytes and classification of the panniculitides. Semin Cutan Med Surg. 2007 Jun;26(2):66-70. doi: 10.1016/j.sder.2007.02.001.

  PMID: 17544956 BACKGROUND

• Requena L, Sanchez Yus E. Panniculitis. Part II. Mostly lobular panniculitis. J Am Acad Dermatol. 2001 Sep;45(3):325-61; quiz 362-4. doi: 10.1067/mjd.2001.114735.

  PMID: 11511831 BACKGROUND

• Requena L, Yus ES. Panniculitis. Part I. Mostly septal panniculitis. J Am Acad Dermatol. 2001 Aug;45(2):163-83; quiz 184-6. doi: 10.1067/mjd.2001.114736.

  PMID: 11464178 BACKGROUND

MeSH Terms

Conditions

Panniculitis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Suthinee Rutnin, MD

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 21, 2025
• Study Start: February 24, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

TH (1)