RecruitingNCT06751355

Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial


Sponsor

Washington University School of Medicine

Enrollment

30 participants

Start Date

Feb 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

While tremendous progress has been made against HIV, both in preventing the infection and in treating AIDS, the disease it causes, AIDS-related malignancies like Kaposi sarcoma (KS) remain a significant health burden, in both the U.S. and especially the developing world. In many cases, multiple KS lesions develop simultaneously, and may progress and regress independently. Photographs are an essential part of the evaluation for KS, as reflected in their formal usage described in the KS Tumor Assessment Manual of Procedures. However, acquiring a clear, informative photo is not trivial, since anatomy is 3D and conventional imaging is 2D. The importance of accurate, quantitative 3D information is especially pronounced for the treatment of KS because when a tumor responds positively to treatment, the initial change is usually a flattening of the lesion, without any significant change in the projected 2D area. To evaluate the vertical space, along with other characteristics of a KS lesion, we have created an innovative imaging system, SkinScan3D, utilizing new commercial liquid lens technologies and AI based image analysis software, with strategies borrowed from astronomical imaging techniques previously used on NASA space telescopes. In this study, the investigators will develop and demonstrate a protocol for recording measurable 3D parameters, which may be used in a longitudinal study to rigorously monitor therapeutic responses of KS and statistically compare with that of the conventional AMC criteria.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new imaging technique using a special device to assess Kaposi sarcoma skin lesions — a cancer caused by a virus that mainly affects people with weakened immune systems, such as those living with HIV. The goal is to see if this imaging technology can more accurately measure the size and extent of the lesions compared to visual inspection alone. **You may be eligible if...** - You have been diagnosed with Kaposi sarcoma, confirmed by a tissue sample - You have at least 3 visible skin lesions from the cancer - You are 18 or older - You are able to provide informed consent **You may NOT be eligible if...** - You have fewer than 3 skin lesions - You have not had a tissue biopsy confirming Kaposi sarcoma - You are unable or unwilling to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESkinScan3D camera

The SkinScan3D (SS3D) is a portable, battery-powered imaging prototype which can successfully achieve all-focus, 3D images using low-cost, off-the-shelf components.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06751355


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