Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06751355
Acronym
PRIME-KS
Enrollment
30
Registered
2024-12-27
Start date
2025-02-25
Completion date
2028-07-31
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kaposi Sarcoma

Keywords

Kaposi, Imaging, Photography, 3D

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.

Interventions

DEVICESkinScan3D camera

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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Pensievision
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of successful capture of high-quality 3D images of cutaneous KS lesionsBaseline 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.
Time to detect response or failure to treatment (Cohort B only)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.

Countries

United States

Contacts

CONTACTLee Ratner, M.D., Ph.D.
lratner@wustl.edu314-362-8836
PRINCIPAL_INVESTIGATORLee Ratner, M.D., Ph.D.

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026