Clinical trial · Interventional
Deep Optical Imaging of Tissue (DOIT)
Measurement and Imaging Capability of a Novel Medical Imaging Method, Ultrasound Optical Tomography, Based on Ultrasound and Laser Light in Human Tissue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast | — | UNRESOLVED | — |
| Extremity | — | UNRESOLVED | — |
| Healthy Tissue | — | UNRESOLVED | — |
| Muscles | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mk1 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Academic, open, single-center, exploratory proof-of-concept study
- description
- The investigational device, Mk1, will be used to image arms, legs, and breast tissue of healthy participants.
- interventionNames
- Device: Mk1
Primary outcomes (1)
- measure
- Depth of imaging
- timeFrame
- Day 1
- description
- Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).
Secondary outcomes (6)
- measure
- Signal variability
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDSheikh R, Cinthio M, Dahlstrand U, Erlov T, Naumovska M, Hammar B, Zackrisson S, Jansson T, Reistad N, Malmsjo M. Clinical Translation of a Novel Photoacoustic Imaging System for Examining the Temporal Artery. IEEE Trans Ultrason Ferroelectr Freq Control. 2019 Mar;66(3):472-480. doi: 10.1109/TUFFC.2018.2868674. PMID 30872212
- BACKGROUNDKhodaverdi A, Cinthio M, Reistad E, Erlov T, Malmsjo M, Zackrisson S, Reistad N. Optical tuning of copolymer-in-oil tissue-mimicking materials for multispectral photoacoustic imaging. Biomed Phys Eng Express. 2024 Jul 15;10(5). doi: 10.1088/2057-1976/ad5e85. PMID 38959869
- BACKGROUNDTomic H, Costa AC, Bjerken A, Vieira MAC, Zackrisson S, Tingberg A, Timberg P, Dustler M, Bakic PR. Simulation of breast lesions based upon fractal Perlin noise. Phys Med. 2023 Oct;114:102681. doi: 10.1016/j.ejmp.2023.102681. Epub 2023 Sep 23. PMID 37748358
- BACKGROUNDBarufaldi B, Maidment ADA, Dustler M, Axelsson R, Tomic H, Zackrisson S, Tingberg A, Bakic PR. VIRTUAL CLINICAL TRIALS IN MEDICAL IMAGING SYSTEM EVALUATION AND OPTIMISATION. Radiat Prot Dosimetry. 2021 Oct 12;195(3-4):363-371. doi: 10.1093/rpd/ncab080. PMID 34144597
- BACKGROUNDHill D, Bengtsson A, Erlov T, Cinthio M, Kroll S. Acousto-optic interaction strengths in optically scattering media using high pressure acoustic pulses. Biomed Opt Express. 2021 May 7;12(6):3196-3213. doi: 10.1364/BOE.421636. eCollection 2021 Jun 1. PMID 34221654
- BACKGROUNDBengtsson A, Hill D, Li M, Di M, Cinthio M, Erlov T, Andersson-Engels S, Reistad N, Walther A, Rippe L, Kroll S. Characterization and modeling of acousto-optic signal strengths in highly scattering media. Biomed Opt Express. 2019 Oct 7;10(11):5565-5584. doi: 10.1364/BOE.10.005565. eCollection 2019 Nov 1. PMID 31799031
- BACKGROUNDGunther J, Walther A, Rippe L, Kroll S, Andersson-Engels S. Deep tissue imaging with acousto-optical tomography and spectral hole burning with slow light effect: a theoretical study. J Biomed Opt. 2018 Apr;23(7):1-8. doi: 10.1117/1.JBO.23.7.071209.