Clinical trial · Interventional
The Feasibility of Multispectral Optoacoustic Tomography in Different Diseases
The Feasibility of Multispectral Optoacoustic Tomography in Different Diseases: a Phase 1 Explorative Imaging Study (FOMO-study)
- 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)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arterial Disease | — | UNRESOLVED | — |
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
| Sjogren Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multispectral optoacoustic tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental MSOT measurement
- description
- imaged with the multispectral optoacoustic tomography device (MSOT Acuity Echo).
- interventionNames
- Device: Multispectral optoacoustic tomography
Primary outcomes (3)
- measure
- Optoacoustic Signal Analysis
- timeFrame
- After informed consent the patient will be imaged for 15 minutes.
- description
- 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.)
- measure
- Comparison with Standard Imaging Modalities
- timeFrame
- After informed consent the patient will be imaged for 15 minutes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with the following diseases will be included: 1. Morbus Sjögren, 2. A superficially located malignant tumor \< 5 centimeter beneath the skin 3. (Peripheral) arterial disease * Age ≥ 18 years; Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available