Clinical trial · Observational
Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kaposi Sarcoma | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SkinScan3D camera | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A: No treatment
- description
- 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.
- label
- Cohort B: Active treatment
- description
- 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.
Primary outcomes (2)
- measure
- Rate of successful capture of high-quality 3D images of cutaneous KS lesions
- timeFrame
- Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available