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Clinical Trials in Sweden / NCT07754500
Recruiting Not applicable

Deep Optical Imaging of Tissue (DOIT)

NCT07754500 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lund University
Phase
Not applicable
Started
2025-11-25
Last updated
2026-08-10

Condition(s) studied

Healthy TissueMusclesExtremityBreast

Investigational drug(s) / intervention(s)

Mk1

Mk1: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy individuals without systemic or skin-related conditions. * Ability to provide informed consent. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Depth of imaging — Day 1
    Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).

Trial sites (1)

FacilityCityRegionStatus
Lund University Malmö Skåne County Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07754500 on ClinicalTrials.gov ↗ ← All trials in Sweden