Recruiting

Precision Imaging

Sponsor:

Washington University School of Medicine

Code:

NCT06751355

Conditions

Kaposi Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SkinScan3D camera

Study Details

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

Study ID

NCT06751355

Start date

Feb 25, 2025

Status verified date

Mar, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

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

314-362-8836lratner@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

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

314-362-8836lratner@wustl.edu

Principal Investigator:

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

More Information

Sponsor

Washington University School of Medicine

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • Kaposi
  • Imaging
  • Photography
  • 3D

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-03-25.