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NCT Number: NCT06898203

Precision Imaging to Evaluate Kaposi Sarcoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute, Kisumu, Kenya

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SkinScan3D

Device

A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).

Other names: SS3D

Primary outcomes

  1. Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only

    Time frame: Approximately 3 months

    Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.

  2. Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only

    Time frame: Approximately 3 months

    Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1.

  3. Device usability - Aim 3 Only

    Time frame: 6 months

    Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score.

  4. Acceptability - Aim 3 Only

    Time frame: 6 months

    Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention.

  5. Appropriateness - Aim 3 Only

    Time frame: 6 months

    Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness.

  6. Feasibility - Aim 3 Only

    Time frame: 6 months

    FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from "completely disagree" to "completely agree"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Odeny, MBChB, MPH, PhD

CONTACT

[email protected]

314-273-3022

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Kenya Medical Research Institute
  • Makerere University
  • National Cancer Institute (NCI)
  • Pensievision

Registry information

Official study title

Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)

Acronym: PRIME-KS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 27, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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