Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Patients will enroll at Siteman Cancer Center at Washington University School of Medicine.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SkinScan3D camera

    Device

    The SkinScan3D (SS3D) is a portable, battery-powered imaging prototype which can successfully achieve all-focus, 3D images using low-cost, off-the-shelf components.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cohort A: No treatment0 interventions
Group B: Cohort B: Active treatment0 interventions

Trial outcomes

Primary outcomes

1

Rate of successful capture of high-quality 3D images of cutaneous KS lesions

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.

Time frame
Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)
2

Time to detect response or failure to treatment (Cohort B only)

Differences between the SkinScan3D and standard 2D in time to detect response or failure to treatment.

Time frame
Baseline and up to 12 additional visits, each visit will take approximately 30 minutes (estimated to be 12 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Pensievision

Collaborator