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

The Washington University

Status: Enrolling

Conditions: Kaposi Sarcoma

Treatments: Device: SkinScan3D camera

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06751355

U01CA292765 (U.S. NIH Grant/Contract)

202501193

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

• Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (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.

Trial design

20 participants in 1 patient group

SkinScan3D

Description:

Consenting and eligible patients will have tumor assessments performed at a single visit. These assessments will be done by ruler or calipers, cell phone 2D photographs, and SS3D camera.

Treatment:

Device: SkinScan3D camera