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

NCT06751355 | Recruiting FDA Device

• 2 other identifiers: 202501193U01CA292765
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kaposi Sarcoma

Keywords

Kaposi; Imaging; Photography; 3D

Outcome Measures

Primary Outcomes (2)

• Rate of successful capture of high-quality 3D images of cutaneous KS lesions

  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.

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

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

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

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

Study Arms (2)

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.

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.

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.

Also known as: SS3D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will enroll at Siteman Cancer Center at Washington University School of Medicine.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pensievision: collaborator
• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Sarcoma, Kaposi

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Study Officials

• Lee Ratner, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

314-362-8836; lratner@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)