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.
Optical tissue imaging can provide biomolecular contrast that is not readily reachable with other imaging modalities. The investigators focus on developing a technique for instantaneous measurements of blood oxygenation which have significant influence in many areas like tumour detection, myocardial infarction, or stroke. However, the technique can in addition to tissue oxygenation also in general measure the optical absorption and scattering properties of tissue, and this is what the investigators will develop and further capitalize on in this project. In general, the spatial resolution of tissue diagnostics using optical techniques is limited to a few cm due to the strong scattering properties of tissue. Using quantum designed filter structures with large acceptance angle that are many orders of magnitude narrower than any other large acceptance angle filters, this technique can image deeper into tissue with significantly better contrast-to-noise than other optical techniques. By analyzing the frequency shifted light only, a spatial resolution equal to the ultrasound focus can be obtained. This technique is called Ultrasound Optical Tomography (UOT). A critical factor in UOT is the ability to discriminate between the light frequency-shifted by the ultrasound and the much stronger non-frequency-shifted light. The absorption of ultrasound in tissue increases with increasing ultrasound frequency, and therefore the ultrasound frequency preferably should be just a few MHz. The small frequency shift is why previous attempts to develop UOT techniques have had limited success: conventional filtering techniques are either not narrow enough to suppress only the carrier or has a very small acceptance angle - a serious drawback as light exiting tissue propagates in all directions. The Quantum Information Group at the Division of Atomic Physics, Department of Physics at Lund University, has world leading experience in creating narrowband (1 MHz) filters with high (\~50 dB) suppression as well as a large acceptance angle. These so-called Slow Light Filters are created in inorganic crystals doped by rare-earth ions, where laser light is used to semi-permanently transfer ions to non-absorbing states. The filters are created by "burning" a spectral hole in the absorption profile of the crystal at the frequency fS so that it transmits this frequency but absorbs the unwanted background light at the frequency fL. An added and important effect of these filters is that light propagating at the transmitted frequency, fS, will be slowed down by several orders of magnitude. In this way, any remaining background from the carrier frequency after the filter can be suppressed using time gating. In terms of combined suppression of non-frequency shifted light and acceptance angle for the frequency shifted light, slow-light filters outperform currently existing filters by several orders of magnitude, in turn enabling orders of magnitude better contrast for tissue imaging. In summary, UOT is an emerging technology which is predicted to reach much deeper than previous optical imaging techniques and to have an order of magnitude better signal-to noise or contras-to-noise already at 1 cm depth and 2 orders of magnitude stronger signal at 2 cm depth. It is unique in the sense of being an optical imaging technique expected to be able to utilize light transmitted through 10 cm of tissue, a feature not present in any other optical imaging technique. In this first proof-of-concept project the investigators will primarily assess the imaging depth and imaging quality in muscle and breast tissue to be able to adapt the system to better performance before moving to early clinical trials. Muscle tissue oxygenation is well studied using optical techniques and is therefore suitable for validation of UOT measurements. Breast is expected to be an excellent first clinical performance test model since the organ has a rather superficial and accessible anatomical position and offer many conventional techniques for cross-referencing. If UOT is successful in breast, it may be further developed for applications in other parts of the body and organs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
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.
Lund University
Malmö, Skåne County, Sweden
RECRUITINGDepth of imaging
Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).
Time frame: Day 1
Signal variability
Variability in UOT signals between individuals (measured as standard deviation or coefficient of variation).
Time frame: Day 1
Intra-individual variability (e.g., across different anatomical locations or repeated measurements).
(e.g., across different anatomical locations or repeated measurements).
Time frame: Day 1
Normal tissue mapping
Distribution of UOT signals in arm and leg regions (mean and standard deviation for HbO2 and Hb).
Time frame: Day 1
Breast tissue mapping:
Distribution of UOT signals in breast regions (mean and standard deviation for HbO2 and Hb).
Time frame: Day 1
Imaging success rate
percentage of participants where all intended regions were successfully imaged
Time frame: Day 1
Functional imaging
Quantification of oxygenation levels (HbO2, Hb) at various depths. Comparison of optical absorption values for different tissue types.
Time frame: Day 1
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