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Measurement and Imaging Capability of a Novel Medical Imaging Method, Ultrasound Optical Tomography, Based on Ultrasound and Laser Light in Human Tissue

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In medical imaging, X-ray-based methods are widely used, which means that patients are exposed to ionizing radiation. In addition, invasive tissue samples often need to be taken with biopsy needles to, for example, safely determine or rule out a cancer diagnosis. With this project, the investigators evaluate a light-based (optical) method combined with ultrasound that is completely harmless to humans, ultrasound-optical-tomography (UOT). UOT is predicted to be able to penetrate deeper into the body to measure functions and image tissues than was previously possible with other optical imaging methods. The aim of this project is to explore the capabilities and safety of UOT regarding imaging depth and tissue property information in healthy participants, as a first step to understand the technology's capabilities and limitations. The long-term goal, in future steps, is to develop the technology for clinical assessment of cancer-suspected lesions with a particular focus on breast cancer and for assessment of circulatory disorders in tissue.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Healthy individuals without systemic or skin-related conditions.

• Ability to provide informed consent.

Locations
Other Locations
Sweden
Lund University
RECRUITING
Malmö
Contact Information
Primary
Sophia Zackrisson, MD PhD
Sophia.zackrisson@med.lu.se
+46736874149
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2027-12
Participants
Target number of participants: 60
Treatments
Experimental: Academic, open, single-center, exploratory proof-of-concept study
The investigational device, Mk1, will be used to image arms, legs, and breast tissue of healthy participants.
Related Therapeutic Areas
Sponsors
Leads: Lund University

This content was sourced from clinicaltrials.gov