Precision Imaging to Evaluate Kaposi Sarcoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults age ≥18 years old

Histopathology-confirmed Kaposi Sarcoma

At least 3 skin lesions

Capable of informed consent

Disqualifiers

Patients not initiating Kaposi Sarcoma treatment

Very ill patients requiring hospitalization

Adults age ≥18 years old

Histopathology-confirmed Kaposi Sarcoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • SkinScan3D

    Device

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Aim 2: PatientsOther 1 intervention
Group B: Aim 3: PatientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Approximately 3 months
2

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

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.

Time frame
Approximately 3 months
3

Device usability - Aim 3 Only

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.

Time frame
6 months
4

Acceptability - Aim 3 Only

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Pensievision

Collaborator

Kenya Medical Research Institute

Collaborator

Makerere University

Collaborator