Clinical trial NCT06838988: Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules
Official title: Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nodules
Ultrasonography
Panniculitis
Keywords: Nodules
Ultrasonography
panniculitis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: Panniculitis refers to a group of conditions involving inflammation of the fat cells in the subcutaneous tissue. It can result from various causes, such as inflammation, infection, vasculitis (inflammation of blood vessels), or lymphoproliferative disorders (abnormal lymphocyte proliferation). In general, it is challenging to determine the cause of subcutaneous tissue inflammation based solely on skin manifestations, as patients often present with similar symptoms, such as subcutaneous lumps, tenderness, and redness, usually found in the lower limbs. Therefore, diagnosis often requires a comprehensive patient history taking, physical examinations, and sometimes biopsy for histopathological examination to confirm the diagnosis. Occasionally, additional tests, including immunohistochemistry, cultures, or polymerase chain reaction (PCR), may be necessary for greater diagnostic accuracy.

Since 1997, Ackerman has proposed diagnostic guidelines for panniculitis based on histopathological findings, initially categorizing it according to the site of inflammation into septal panniculitis and lobular panniculitis. Further classification considers whether vasculitis is present. However, even with physical examination and histopathological analysis, accurately classifying panniculitis remains challenging. In 2007, Requena and colleagues highlighted limitations in biopsy, such as the selection of lesions with differing characteristics or lesions at different stages, resulting in varying histopathological features. Moreover, the depth or insufficient amount of tissue collected for biopsy may reduce diagnostic accuracy.

Since 1979, medical advancements have led to the increased use of ultrasound in dermatological diagnosis. Low-frequency ultrasound machines (2 MHz) were initially used to examine skin lesions, such as skin inflammation or subcutaneous nodules. In 1983, Miyauchi and colleagues began using higher-frequency ultrasound (10 MHz) to study ultrasound characteristics compared to histopathological results in patients presenting with subcutaneous or dermal nodules. Over time, the use of higher-frequency ultrasound became more common, as it provides better detail and convenience, being a simple, safe, and cost-effective procedure.

For panniculitis, research has shown that ultrasound can assist in diagnosis. In 2020, Romani and colleagues studied the correlation between ultrasound findings and histopathology in 62 cases of panniculitis. Septal panniculitis typically shows thickening of the septa with hypoechoic areas resembling a jigsaw pattern, difficult to compress, increased blood flow, and possible clotting in veins. Lobular panniculitis shows hyperechoic fat with irregular borders, without septal thickening or increased vascularity, and may show fat necrosis or extension into muscles and adjacent tissues. However, further research is needed for clear differentiation between types of panniculitis based on ultrasound features.

Subsequent studies have used ultrasound to describe various forms of panniculitis, including those caused by gout, erythema nodosum, lupus erythematosus, and subcutaneous T-cell lymphoma, among others.

In conclusion, diagnosing panniculitis in patients with subcutaneous nodules remains challenging and relies on a combination of physical examination, patient history, histopathology, and sometimes additional tests like immunohistochemistry, cultures, or PCR. These diagnostic procedures can lead to unnecessary testing and delays in diagnosis. Ultrasound data can assist in selecting appropriate laboratory tests, facilitate diagnosis and treatment monitoring, and aid in selecting biopsy sites. However, there is no comprehensive collection of ultrasound data for different conditions, which is why this study was conducted to gather this information and explore the correlation between ultrasound findings and histopathological features for more accurate diagnosis.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Subcutaneous echogenicity
timeFrame: Through study completion averaging 2 years
Secondary outcomes:
measure: Subcutaneous fat septum thickness
timeFrame: Through study completion averaging 2 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
state: Ratchathewi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.