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NCT Number: NCT06751355

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Feng Gao, Ph.D.

SUB_INVESTIGATOR

Lee Ratner, M.D., Ph.D.

CONTACT

[email protected]

314-362-8836

Lee Ratner, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Thomas Odeny, MBChB, MPH, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SS3D

Primary outcomes

  1. 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)

    Feasibility is defined as > 90% of lesions captured in the conventional imaging procedures are also seen in the SkinScan3D data, and that unique height and volume data is captured by the SkinScan3D for > 70% of lesions.

  2. Time to detect response or failure to treatment (Cohort B only)

    Time frame: Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)

    Differences between the SkinScan3D and standard 2D in time to detect response or failure to treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Ratner, M.D., Ph.D.

CONTACT

[email protected]

314-362-8836

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • Pensievision

Registry information

Acronym: PRIME-KS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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