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

Recruiting

• Conditions: Kaposi Sarcoma

• Registration Number: NCT06751355
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Status Verified: 2025-02
• Study Start: 2025-02-25
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of capturing 3D images of cutaneous KS lesions	Day 1	Feasibility is defined as \> 90% of lesions captured in the conventional imaging procedures are also seen in the SkinScan3D data and \> 70% of lesions detected with SkinScan3D result in a measurable 3D shape not available in the conventional measurement (and quantitative color measurements are achieved for \> 90% of such lesions).

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States