跳至主要内容
临床试验/NCT07754500
NCT07754500招募中不适用

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

Lund University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Depth of imaging

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals without systemic or skin-related conditions.
  • Ability to provide informed consent.

排除标准

  • Pregnancy: Although the risk that laser illumination on the skin may affect the fetus is minimal, we will exclude pregnant research subjects for safety.
  • Skin diseases: Certain skin conditions can increase the risk of damage or complications when exposed to laser light, such as active rosacea, eczema, skin infections, or tattoos.
  • Medication: Some medications can increase the sensitivity of the skin to laser light or increase the risk of side effects. It is important to consider the person's medical history and any ongoing treatments.
  • Sunburn: Recent sun exposure of the skin may lead to increased sensitivity to laser light and can be more likely to experience discomfort or skin irritation/damage. This can both affect the reliability of the study and increase the risk of injury to the research subjects.
  • History of keloid formation or scarring: People who have a history of excessive scarring may be more likely to react with greater skin irritation from the laser light.
  • For breast measurements only: History of breast cancer or surgery. In this project, we aim to map the UOT signal only in healthy breast tissue.

研究组 & 干预措施

Academic, open, single-center, exploratory proof-of-concept study

Experimental

The investigational device, Mk1, will be used to image arms, legs, and breast tissue of healthy participants.

干预措施: Mk1 (Device)

结局指标

主要结局

Depth of imaging

时间窗: Day 1

Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).

次要结局

  • Signal variability(Day 1)
  • Intra-individual variability (e.g., across different anatomical locations or repeated measurements).(Day 1)
  • Normal tissue mapping(Day 1)
  • Breast tissue mapping:(Day 1)
  • Imaging success rate(Day 1)
  • Functional imaging(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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