- The technical feasibility of multispectral optoacoustic tomography for the localization and assessment of disease-specific tissue in a particular anatomical area- Detection of endogenous biomarkers for the characterization in a variety of diseases…
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
- Skin neoplasms malignant and unspecified
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The technical feasibility of optoacoustic imaging of disease-specific tissue
in different diseases
- Quantification of endogenous optoacoustic signals from various endogenous
absorbers as observed by the MSOT Acuity Echo.
Secondary outcome
-
Background 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.
Study objective
- The technical feasibility of multispectral optoacoustic tomography for the
localization and assessment of disease-specific tissue in a particular
anatomical area
- Detection of endogenous biomarkers for the characterization in a variety of
diseases
Study design
The current study is a single center, prospective, cross-sectional, explorative
study. The study procedures will be performed at the University Medical Center
Groningen, Department of Nuclear Medicine and Molecular Imaging.
Study burden and risks
Burden
Patients will be imaged immediately after their appointment at the outpatient
clinic. The patient will undergo one imaging moment of maximum 15 minutes, no
other study related procedures will be performed. Healthy volunteers will
undergo one imaging moment of 15 minutes.
Risks
A potential hazard of applying MSOT imaging is cornea damage, as well for the
patient as the operator, which is taken care of by a laser safety
Standard-Operating-Procedure as everyone present in the MSOT room is obligated
to wear laser safety goggles. The residual risk of MSOT is slight, reversible
reddening and temperature increase of the skin.
Benefit
Patients will have no direct benefit from this study.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Patients with the following diseases will be included:
a. Morbus Sjögren,
b. A superficially located malignant tumor < 5 centimeter beneath the skin
c. (Peripheral) arterial disease
2. Age >= 18 years;
Exclusion criteria
1. Patients with disease localizations or manifestations that do not enable
good coupling between the optoacoustic probe and the skin, as decided by the
researchers;
2. Medical or psychiatric conditions that compromise the patient*s ability to
give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinical trials register nummer volgt |
| CCMO | NL71894.042.19 |