NCT06751355 Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
| NCT ID | NCT06751355 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Kaposi Sarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-02-25 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria: * 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. * Ability to understand and willingness to sign an IRB approved written informed consent document.
Contact & Investigator
Lee Ratner, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06751355 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kaposi Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06751355 currently recruiting?
Yes, NCT06751355 is actively recruiting participants. Contact the research team at lratner@wustl.edu for enrollment information.
Where is the NCT06751355 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT06751355 clinical trial?
NCT06751355 is sponsored by Washington University School of Medicine. The principal investigator is Lee Ratner, M.D., Ph.D. at Washington University School of Medicine. The trial plans to enroll 30 participants.