Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SkinScan3D camera.
- Who it may be relevant to
- Registry conditions: Kaposi Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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 measures
- 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)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT06751355 · 202501193 · U01CA292765