Deep Optical Imaging of Tissue (DOIT)

NCT07754500 | Recruiting DMC

• 1 other identifier: CIV-24-10-049581
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Tissue; Muscles; Extremity; Breast

Keywords

Optical Imaging; Tissue Oxygenation; Breast / Breast Neoplasms; Hemoglobin; Photoacoustic Techniques; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Depth of imaging

  Maximum tissue depth where a reliable signal is achieved for both wavelengths (689 nm and 794 nm).

  Day 1

Secondary Outcomes (6)

• Signal variability

  Day 1

• Intra-individual variability (e.g., across different anatomical locations or repeated measurements).

  Day 1

• Normal tissue mapping

  Day 1

• Breast tissue mapping:

  Day 1

• Imaging success rate

  Day 1

Other Outcomes (1)

• Frequency and severity of adverse events

  Up until 24 hours

Study Arms (1)

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.

Device: Mk1

Interventions

Mk1 DEVICE

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.

Academic, open, single-center, exploratory proof-of-concept study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals without systemic or skin-related conditions.
• Ability to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University

Malmö, Skåne County, 20502, Sweden

RECRUITING

Related Publications (12)

• 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.

  PMID: 30872212 BACKGROUND

• Khodaverdi 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 BACKGROUND

• Tomic 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 BACKGROUND

• Barufaldi 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 BACKGROUND

• Hill 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 BACKGROUND

• Bengtsson 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 BACKGROUND

• Gunther 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.

  PMID: 29701019 BACKGROUND

• Bengtsson 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.

  PMID: 36187237 BACKGROUND

• Walther 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.

  PMID: 29082082 BACKGROUND

• Zhang 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.

  PMID: 22509069 BACKGROUND

• Skarping 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.

  PMID: 33063567 BACKGROUND

• Kinos 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.

  PMID: 28059275 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sophia Zackrisson, MD PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Zackrisson, MD PhD

CONTACT

+46736874149; Sophia.zackrisson@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: August 10, 2026
• Study Start: November 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)