Healthy TissueDOITNCT07754500
Deep Optical Imaging of Tissue (DOIT)
A study testing Mk1 in people with Healthy Tissue and Muscles, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Tissue, Muscles, Extremity
- What is being tested?
- Mk1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 25 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals without systemic or skin-related conditions.
- Ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Lund University
Malmö, Skåne County, 20502
Sophia Zackrisson, MD PhD, +46736874149, Sophia.zackrisson@med.lu.se
About this study
Official title: Measurement and Imaging Capability of a Novel Medical Imaging Method, Ultrasound Optical Tomography, Based on Ultrasound and Laser Light in Human Tissue
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.
Read the detailed description
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.
In terms of combined suppression of non-frequency shifted light and acceptance angle for the frequency shifted light, slow-light filters outperform currently existing filters by several orders of magnitude, in turn enabling orders of magnitude better contrast for tissue imaging.
In summary, UOT is an emerging technology which is predicted to reach much deeper than previous optical imaging techniques and to have an order of magnitude better signal-to noise or contras-to-noise already at 1 cm depth and 2 orders of magnitude stronger signal at 2 cm depth. It is unique in the sense of being an optical imaging technique expected to be able to utilize light transmitted through 10 cm of tissue, a feature not present in any other optical imaging technique. In this first proof-of-concept project the investigators will primarily assess the imaging depth and imaging quality in muscle and breast tissue to be able to adapt the system to better performance before moving to early clinical trials. Muscle tissue oxygenation is well studied using optical techniques and is therefore suitable for validation of UOT measurements. Breast is expected to be an excellent first clinical performance test model since the organ has a rather superficial and accessible anatomical position and offer many conventional techniques for cross-referencing. If UOT is successful in breast, it may be further developed for applications in other parts of the body and organs.
- Conditions
- Healthy Tissue, Muscles, Extremity, Breast
- Being tested
- Mk1
- Keywords
- Optical Imaging, Tissue Oxygenation, Breast / Breast Neoplasms, Hemoglobin, Photoacoustic Techniques, Healthy Volunteers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mk1Device
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mk1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of imaging
Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).
Measured: Day 1
Secondary outcomes (6)
Signal variability
Variability in UOT signals between individuals (measured as standard deviation or coefficient of variation).
Measured: Day 1
Intra-individual variability (e.g., across different anatomical locations or repeated measurements).
(e.g., across different anatomical locations or repeated measurements).
Measured: Day 1
Normal tissue mapping
Distribution of UOT signals in arm and leg regions (mean and standard deviation for HbO2 and Hb).
Measured: Day 1
Breast tissue mapping:
Distribution of UOT signals in breast regions (mean and standard deviation for HbO2 and Hb).
Measured: Day 1
Imaging success rate
percentage of participants where all intended regions were successfully imaged
Measured: Day 1
Functional imaging
Quantification of oxygenation levels (HbO2, Hb) at various depths. Comparison of optical absorption values for different tissue types.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start25 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Healthy TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To get a good oversight of signal variability in different kinds of healthy tissue (extremities and breast), we have decided on in total 60 participants: * One wavelength imaging; 30 extremities (half female, half men), 10 female participants for breasts. * Two wavelengths: 10 female participants for breasts.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophia Zackrisson, MD PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754500
- Sponsor's protocol ID
- CIV-24-10-049581
- Acronym
- DOIT
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sheikh 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.
PubMed 30872212Khodaverdi 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.
PubMed 38959869Tomic 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.
PubMed 37748358Barufaldi 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.
PubMed 34144597Hill 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.
PubMed 34221654Bengtsson 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.
PubMed 31799031Gunther 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.
PubMed 29701019Bengtsson A, Hill D, Shortiss K, Rippe L, Kroll S. Comparison of contrast-to-noise ratios of different detection methods in ultrasound optical tomography. Biomed Opt Express. 2022 Aug 18;13(9):4834-4850. doi: 10.1364/BOE.457075. eCollection 2022 Sep 1.
PubMed 36187237Walther A, Rippe L, Wang LV, Andersson-Engels S, Kroll S. Analysis of the potential for non-invasive imaging of oxygenation at heart depth, using ultrasound optical tomography (UOT) or photo-acoustic tomography (PAT). Biomed Opt Express. 2017 Sep 19;8(10):4523-4536. doi: 10.1364/BOE.8.004523. eCollection 2017 Oct 1.
PubMed 29082082Zhang H, Sabooni M, Rippe L, Kim C, Kroll S, Wang LV, Hemmer PR. Slow light for deep tissue imaging with ultrasound modulation. Appl Phys Lett. 2012 Mar 26;100(13):131102-1311025. doi: 10.1063/1.3696307.
PubMed 22509069Skarping I, Fornvik D, Heide-Jorgensen U, Ryden L, Zackrisson S, Borgquist S. Neoadjuvant breast cancer treatment response; tumor size evaluation through different conventional imaging modalities in the NeoDense study. Acta Oncol. 2020 Dec;59(12):1528-1537. doi: 10.1080/0284186X.2020.1830167. Epub 2020 Oct 16.
PubMed 33063567Kinos A, Li Q, Rippe L, Kroll S. Development and characterization of high suppression and high etendue narrowband spectral filters. Appl Opt. 2016 Dec 20;55(36):10442-10448. doi: 10.1364/AO.55.010442.
PubMed 28059275
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Imaging Capability of a Novel Medical Imaging Method, Ultrasound Optical Tomography, Based on Ultrasound and Laser Light in Human Tissue
- ClinicalTrials.gov ID
- NCT07754500
- Acronym / sponsor ID
- DOIT / CIV-24-10-049581
- Conditions
- Healthy Tissue, Muscles, Extremity, Breast
- Keywords
- Optical Imaging, Tissue Oxygenation, Breast / Breast Neoplasms, Hemoglobin, Photoacoustic Techniques, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In terms of combined suppression of non-frequency shifted light and acceptance angle for the frequency shifted light, slow-light filters outperform currently existing filters by several orders of magnitude, in turn enabling orders of magnitude better contrast for tissue imaging.
In summary, UOT is an emerging technology which is predicted to reach much deeper than previous optical imaging techniques and to have an order of magnitude better signal-to noise or contras-to-noise already at 1 cm depth and 2 orders of magnitude stronger signal at 2 cm depth. It is unique in the sense of being an optical imaging technique expected to be able to utilize light transmitted through 10 cm of tissue, a feature not present in any other optical imaging technique. In this first proof-of-concept project the investigators will primarily assess the imaging depth and imaging quality in muscle and breast tissue to be able to adapt the system to better performance before moving to early clinical trials. Muscle tissue oxygenation is well studied using optical techniques and is therefore suitable for validation of UOT measurements. Breast is expected to be an excellent first clinical performance test model since the organ has a rather superficial and accessible anatomical position and offer many conventional techniques for cross-referencing. If UOT is successful in breast, it may be further developed for applications in other parts of the body and organs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To get a good oversight of signal variability in different kinds of healthy tissue (extremities and breast), we have decided on in total 60 participants: * One wavelength imaging; 30 extremities (half female, half men), 10 female participants for breasts. * Two wavelengths: 10 female participants for breasts.
| Arm | Type | Receives |
|---|---|---|
| Academic, open, single-center, exploratory proof-of-concept study | Experimental | Device: Mk1The investigational device, Mk1, will be used to image arms, legs, and breast tissue of healthy participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy individuals without systemic or skin-related conditions.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mk1The 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. | Device | Academic, open, single-center, exploratory proof-of-concept study |
Primary outcome
Depth of imaging
Time frame: Day 1
Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).
6 secondary outcomes
Signal variability
Time frame: Day 1
Intra-individual variability (e.g., across different anatomical locations or repeated measurements).
Time frame: Day 1
Normal tissue mapping
Time frame: Day 1
Breast tissue mapping:
Time frame: Day 1
Imaging success rate
Time frame: Day 1
Functional imaging
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 30872212Sheikh 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.
- Background: PubMed 38959869Khodaverdi 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.
- Background: PubMed 37748358Tomic 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.
- Background: PubMed 34144597Barufaldi 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.
- Background: PubMed 34221654Hill 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.
- Background: PubMed 31799031Bengtsson 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.
- Background: PubMed 29701019Gunther 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.
- Background: PubMed 36187237Bengtsson A, Hill D, Shortiss K, Rippe L, Kroll S. Comparison of contrast-to-noise ratios of different detection methods in ultrasound optical tomography. Biomed Opt Express. 2022 Aug 18;13(9):4834-4850. doi: 10.1364/BOE.457075. eCollection 2022 Sep 1.
- Background: PubMed 29082082Walther A, Rippe L, Wang LV, Andersson-Engels S, Kroll S. Analysis of the potential for non-invasive imaging of oxygenation at heart depth, using ultrasound optical tomography (UOT) or photo-acoustic tomography (PAT). Biomed Opt Express. 2017 Sep 19;8(10):4523-4536. doi: 10.1364/BOE.8.004523. eCollection 2017 Oct 1.
- Background: PubMed 22509069Zhang H, Sabooni M, Rippe L, Kim C, Kroll S, Wang LV, Hemmer PR. Slow light for deep tissue imaging with ultrasound modulation. Appl Phys Lett. 2012 Mar 26;100(13):131102-1311025. doi: 10.1063/1.3696307.
- Background: PubMed 33063567Skarping I, Fornvik D, Heide-Jorgensen U, Ryden L, Zackrisson S, Borgquist S. Neoadjuvant breast cancer treatment response; tumor size evaluation through different conventional imaging modalities in the NeoDense study. Acta Oncol. 2020 Dec;59(12):1528-1537. doi: 10.1080/0284186X.2020.1830167. Epub 2020 Oct 16.
- Background: PubMed 28059275Kinos A, Li Q, Rippe L, Kroll S. Development and characterization of high suppression and high etendue narrowband spectral filters. Appl Opt. 2016 Dec 20;55(36):10442-10448. doi: 10.1364/AO.55.010442.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophia Zackrisson, MD PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mk1 in people with Healthy Tissue and Muscles, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Zackrisson, MD PhD (+46736874149, Sophia.zackrisson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of imaging (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07754500, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.