Deep Optical Imaging of Tissue (DOIT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Healthy individuals without systemic or skin-related conditions.
Ability to provide informed consent.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Mk1
DeviceThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Academic, open, single-center, exploratory proof-of-concept studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Depth of imaging
Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).
Time frame
Day 1Secondary outcomes
1
Signal variability
Variability in UOT signals between individuals (measured as standard deviation or coefficient of variation).
Time frame
Day 12
Intra-individual variability (e.g., across different anatomical locations or repeated measurements).
(e.g., across different anatomical locations or repeated measurements).
Time frame
Day 13
Normal tissue mapping
Distribution of UOT signals in arm and leg regions (mean and standard deviation for HbO2 and Hb).
Time frame
Day 14
Breast tissue mapping:
Distribution of UOT signals in breast regions (mean and standard deviation for HbO2 and Hb).
Time frame
Day 1Other outcomes
1
Frequency and severity of adverse events
e.g., skin irritation, discomfort
Time frame
Up until 24 hoursSponsors and contacts
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Source ClinicalTrials.gov