Deep Optical Imaging of Tissue (DOIT)
Measurement and Imaging Capability of a Novel Medical Imaging Method, Ultrasound Optical Tomography, Based on Ultrasound and Laser Light in Human Tissue
Lund University
60 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The Mk1 is an investigational device intended for UOT, a novel imaging method which can image the state of oxygenation of tissues inside the body. It is intended solely for research purposes and not for clinical diagnostic use. The intended purpose of the Mk1 device is to serve as an investigational system to provide initial UOT measurements and images in-vivo. The performance of the system will be characterized with the aim to provide input data regarding the parameters: * Imaging depth * Contrast-to-noise ratio under relevant imaging conditions and depths * Correlating tissue structures seen in conventional B-scan ultrasound with structures seen in the UOT images.
Locations(1)
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NCT07754500