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

Sponsored by Washington University School of Medicine

About this trial

Last updated a month ago

Study ID

202501193

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the Participation Requirements?

Eligibility Criteria: * Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (KS). * Patients may be off treatment or on treatment for their KS. * Has at least 3 cutaneous Kaposi sarcoma lesions. * At least 18 years of age. * Ability to understand and willingness to sign an IRB approved written informed consent document.