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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06751355
Status
Recruiting
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Conditions

  • Kaposi Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SkinScan3D camera — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Cohort A: No treatment
    Consenting and eligible patients will have tumor assessments performed at baseline then up to 12 additional visits (or more if the device cannot collect the data at a visit). These assessments will be done by ruler or calipers, cell phone 2D photographs, and SS3D camera.
  • Arm: Cohort B: Active treatment
    Consenting and eligible patients will have tumor assessments performed at baseline then up to 12 additional visits (or more if the device cannot collect the data at a visit). These assessments will be done by ruler or calipers, cell phone 2D photographs, and SS3D camera.

Primary Outcome Measure

Rate of successful capture of high-quality 3D images of cutaneous KS lesions [ Time Frame: Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Lee Ratner, M.D., Ph.D.
[email protected]
314-362-8836
Lee Ratner, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Thomas Odeny, MBChB, MPH, Ph.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)

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