Using ultrasound to diagnose subcutaneous nodules
Ultrasonographic Patterns and Pathological Correlation in the Diagnosis of Subcutaneous Nodules
This study is testing if using ultrasound can help doctors better diagnose skin nodules before patients have to get a biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bangkok, Ratchathewi) |
| Trial ID | NCT06838988 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ultrasonography as a non-invasive imaging technique for diagnosing subcutaneous nodules. Patients presenting with these nodules and requiring skin biopsies are recruited to undergo ultrasound examinations prior to their biopsies. The ultrasonographic characteristics of the nodules are then compared with the pathological results from the biopsies to assess the diagnostic accuracy of ultrasound in differentiating various conditions associated with skin nodules. This approach aims to improve the understanding and classification of panniculitis and related disorders.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with subcutaneous nodules that require pathological examination.
Not a fit: Patients with conditions that mimic panniculitis or those with significant skin structure alterations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for patients with subcutaneous nodules, leading to more effective treatment plans.
How similar studies have performed: While the use of ultrasound in diagnosing subcutaneous conditions is established, this specific approach to correlating ultrasound findings with pathological results is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bangkok, Ratchathewi
- Ramathibodi Hospital — Bangkok, Ratchathewi, Thailand (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.