Clinical trial · Interventional
Precision Imaging to Evaluate Kaposi Sarcoma
Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
NCT06898203CI-TRIAL-00118337PRIME-KSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
AIMS 2 \& 3: In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.
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 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Aim 2: Patients
- description
- Patients will have three discrete skin lesions measured, with lesion area determined by ACTG criteria utilizing the product of longest perpendicular diameters. Patients will also have five 3D snapshots of each of the three target lesions taken, measuring lesion area automatically using SS3D.
- interventionNames
- Device: SkinScan3D
- type
- OTHER
- label
- Aim 3: Patients
- description
- Providers will first measure KS lesions using the manual ruler-based method as per usual standard of care for the first three months. After the first three months, providers will switch to using SkinScan3D for KS skin lesion measurement.
- interventionNames
- Device: SkinScan3D
Primary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria - Aim 2 (Patients): * Adults age ≥18 years old * Histopathology-confirmed Kaposi Sarcoma * At least 3 skin lesions * Capable of informed consent * On treatment for Kaposi Sarcoma Exclusion Criteria - Aim 2 (Patients): * Patients not initiating Kaposi Sarcoma treatment * Very ill patients requiring hospitalization Inclusion Criteria - Aim 3 (Patients): * Adults age ≥18 years old * Histopathology-confirmed Kaposi Sarcoma * Capable of informed consent * Initiating treatment for Kaposi Sarcoma Exclusion Criteria - Aim 3 (Patients): * Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2 * Prior or ongoing Kaposi Sarcoma treatment
References
Publications (1)
- DERIVEDOdeny TA, Adhiambo HF, Mangale D, Makanga PK, Odeny B, Okuku F, Zhou C, Geng EH, Carson J, Mudhune V, Bukusi EA, Semeere A. Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): protocol for a multicountry novel artificial intelligence-based imaging device. medRxiv [Preprint]. 2026 Jun 4:2026.06.03.26354815. doi: 10.64898/2026.06.03.26354815. PMID 42282156