NodulesNCT06838988
Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules
A study testing Transcutaneous ultrasound in people with Nodules and Ultrasonography, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodules, Ultrasonography, Panniculitis
- What is being tested?
- Transcutaneous ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 24 Feb 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, Ratchathewi, 10400
Panupong Pornsirianant, Doctor of Medicine, +66635375838, panupongpornsirianant@gmail.com
Namthong Wittayabusarakam, Doctor of Medicine, +66812341021, maynt.wit@gmail.com
About this study
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.
Read the 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.
- Conditions
- Nodules, Ultrasonography, Panniculitis
- Being tested
- Transcutaneous ultrasound
- Keywords
- Nodules, Ultrasonography, panniculitis
- Medical subject headings
- Panniculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Transcutaneous ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion averaging 2 years
Secondary 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
Measured: Through study completion averaging 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start24 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for NodulesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suthinee Rutnin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838988
- Sponsor's protocol ID
- MURA2025/83
- Status last verified
- May 2025
- First submitted
- 11 Feb 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16909278Nazzaro 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.
PubMed 34813122Delgado-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.
PubMed 18793979Gaviria 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.
PubMed 26301134Maldonado 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.
PubMed 28633741Romani 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.
PubMed 31245860Catalano 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.
PubMed 33298770Wortsman 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.
PubMed 26887446Nessi 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.
PubMed 2156901Mandava 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.
PubMed 24347861Gropper 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.
PubMed 8486453Requena 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.
PubMed 17544956Requena 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.
PubMed 11511831Requena 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.
PubMed 11464178
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules
- ClinicalTrials.gov ID
- NCT06838988
- Acronym / sponsor ID
- MURA2025/83
- Conditions
- Nodules, Ultrasonography, Panniculitis
- Keywords
- Nodules, Ultrasonography, panniculitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous ultrasonography | Experimental | Diagnostic Test: Transcutaneous ultrasoundThis is a single group study with one intervention arm where every subjects received ultrasonographic evaluations of their skin lesions (subcutaneous nodules) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous ultrasoundThe 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. | Diagnostic test | Transcutaneous ultrasonography |
Primary outcome
Subcutaneous echogenicity
Time frame: Through study completion averaging 2 years
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
1 secondary outcome
Subcutaneous fat septum thickness
Time frame: Through study completion averaging 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Results publication: PubMed 16909278Kang 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.
- Results publication: PubMed 34813122Nazzaro 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.
- Results publication: PubMed 18793979Delgado-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.
- Results publication: PubMed 26301134Gaviria 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.
- Results publication: PubMed 28633741Maldonado 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.
- Results publication: PubMed 31245860Romani 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.
- Results publication: PubMed 33298770Catalano 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.
- Results publication: PubMed 26887446Wortsman 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.
- Results publication: PubMed 2156901Nessi 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.
- Results publication: PubMed 24347861Mandava 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.
- Results publication: PubMed 8486453Gropper 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.
- Results publication: PubMed 17544956Requena 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous ultrasound in people with Nodules and Ultrasonography, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous echogenicity (time frame: Through study completion averaging 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838988, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.