Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
Purpose
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.
Condition
- Kaposi Sarcoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Eligibility Criteria:
- Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| SkinScan3D | Consenting and eligible patients will have tumor assessments performed at a single visit. These assessments will be done by ruler or calipers, cell phone 2D photographs, and SS3D camera. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06751355
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine