Deep Optical Imaging of Tissue (DOIT) (NCT07754500) | Clinical Trial Compass
RecruitingNot Applicable
Deep Optical Imaging of Tissue (DOIT)
Sweden60 participantsStarted 2025-11-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.