The Feasibility of Multispectral Optoacoustic Tomography in Different Diseases

NCT06740175 | Completed

• 1 other identifier: NL71894.042.19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Optoacoustic imaging is a new and innovative imaging technique that combines the high contrast of optical imaging with the penetration depth and high spatial resolution of ultrasonography using the optoacoustic effect. It can resolve different endogenous tissue chromophores and may thereby provide insight in molecular changes associated with disease (-progression). It can be potentially used as an technique for diagnosis, treatment monitoring and disease localization. As the technique is relatively new in the clinical setting, there is not much clinical experience with optoacoustic imaging. The rationale for this study is to assess the technical feasibility of optoacoustic imaging in a variety of disease and to determine endogenous biomarkers for disease characterization for potential diagnosis and/or disease monitoring.

Conditions

Sjogren Syndrome; Malignant Tumors; Arterial Disease

Keywords

Multispectral optoacoustic tomography; Optoacoustic imaging; Sjogren syndrome; Diagnostic; Diagnose; Non-invasive

Outcome Measures

Primary Outcomes (3)

• Optoacoustic Signal Analysis

  Quantitative assessment of optoacoustic signals from tissue chormophores (e.g., hemoglobine, deoxyhemaglobine, water, lipid, and collagen). The signal of the different chormophores are described as arbitrary units (a.u.)

  After informed consent the patient will be imaged for 15 minutes.

• Comparison with Standard Imaging Modalities

  Validation of optoacoustic imaging by comparing chromophore signals to imaging features from CT, MRI, PET, and/or ultrasound. Correlation coefficients or diagnostic accuracy metrics (e.g., sensitivity, specificity, area under the curve).

  After informed consent the patient will be imaged for 15 minutes.

• Histopathological Correlation

  Correlation of optoacoustic findings with histopathological results from biopsy or surgical specimens. Agreement rate or correlation metrics (e.g. p-values)

  After informed consent the patient will be imaged for 15 minutes.

Study Arms (1)

Experimental MSOT measurement

EXPERIMENTAL

imaged with the multispectral optoacoustic tomography device (MSOT Acuity Echo).

Device: Multispectral optoacoustic tomography

Interventions

Multispectral optoacoustic tomography DEVICE

If patients are willing to participate in this study, they are imaged with the multispectral optoacoustic tomography device (MSOT Acuity Echo) at the department of nuclear medicine and molecular imaging. The imaging procedure takes 15 minutes at most.

Experimental MSOT measurement

Eligibility Criteria

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

You may qualify if:

• Patients with the following diseases will be included:
• Morbus Sjögren,
• A superficially located malignant tumor \< 5 centimeter beneath the skin
• (Peripheral) arterial disease
• Age ≥ 18 years;

You may not qualify if:

• Patients with disease localizations or manifestations that do not enable good coupling between the optoacoustic probe and the skin, as decided by the researchers;
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
• Pregnant women. Women of childbearing potential need to undergo a pregnancy test before participation.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University medical center groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Neoplasms; Disease

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 18, 2024
• Study Start: April 7, 2020
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: It will be available after the end date of the study. It will be available for 15 years after the study has ended
• Access Criteria: PI and other researchers on request. They are able to access the Study Protocol and the Clinical Study Report

Locations

NL (1)