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Deep Optical Imaging of Tissue (DOIT)

NCT07754500 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-10

No results posted yet for this study

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

Interventions

DEVICE

Mk1

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.

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Sophia Zackrisson, MD PhD · Lund University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754500 on ClinicalTrials.gov