Precision Imaging to Evaluate Kaposi Sarcoma
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.
- 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
- Kenya, Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
Overview
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.
Interventions
- Device SkinScan3D
A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Primary outcome measures
- Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only [Time frame: Approximately 3 months]
- Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only [Time frame: Approximately 3 months]
- Device usability - Aim 3 Only [Time frame: 6 months]
- Acceptability - Aim 3 Only [Time frame: 6 months]
- Appropriateness - Aim 3 Only [Time frame: 6 months]
- Feasibility - Aim 3 Only [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Kenya · 1 center
- Kenya Medical Research Institute — Kisumu
Uganda · 1 center
- Infectious Diseases Institute, Makerere University — Kampala
Publications
- Odeny 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
Identifiers
NCT: NCT06898203 · 202411179 · U01CA292765