The clinical investigation aims to generate clinical data to support the use of Multispectral Optoacoustic Tomography (MSOT) in clinical practice, its inclusion in diagnostic guidelines and to support its reimbursement, specifically to * Further validate the application with respect to including ulcerative colitis patients * Prepare a study protocol for large-scale clinical validation study in inflammatory bowel disease (IBD) * Successfully execute the clinical validation study
The clinical investigation, EUPHORIA, will pave the way to establish Multispectral Optoacoustic Tomography (MSOT) technology for the non-invasive assessment of intestinal inflammation in patients. EUPHORIA will enable commercialization of the technology by finalizing technical improvements that will increase diagnostic outcome beyond what has been shown in a first feasibility study, will improve usability, prepare CE marking for the new device and validate clinical results in a large clinical investigation. Inflammatory bowel disease (IBD) is a chronic condition, posing significant burden to patients and health care systems. Patients suffer from a relapsing course of intestinal inflammation, and to date, there is no satisfying noninvasive diagnostic modality for monitoring disease activity. In a recent clinical study conducted by University Hospital Erlangen, MSOT, a technology developed by iThera Medical (ITM), has proven to be superior in diagnostic performance to other procedures.
Study Type
OBSERVATIONAL
Enrollment
200
cMSOT-2 system is indicated for measurement of the Multispectral Optoacoustic Tomography (MSOT) values in the bowel wall of patients with an established diagnosis of inflammatory bowel disease (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC). The MSOT values provided may be used as an aid to the assessment of inflammatory disease activity in the bowel wall.
Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30
Berlin, Germany
Universitätsklinikum Erlangen Medizinische Klinik 1
Erlangen, Germany
Universitätsklinikum Jena
Jena, Germany
Policlinico Tor Vergata
Rome, Lazio, Italy
Derivation Cohort: derive optimum diagnostic MSOT thresholds
Derivation cohort: The primary endpoint of the derivation cohort is to derive optimum diagnostic MSOT thresholds based on receiver operating characteristics (ROC) analysis to distinguish endoscopic active disease from remission in Crohn's Disease (CD) or Ulcerative Colitis (UC) patients.
Time frame: 5-10 days
Validation cohort: re-assess the diagnostic accuracy of MSOT
Validation cohort: The primary endpoint of the validation cohort is to re-assess the diagnostic accuracy of MSOT to distinguish endoscopic active disease from remission in an independent cohort. It will be considered successful if a lower 90% confidence of limit at least 75% of area under curve (AUC) is reached
Time frame: 5-10 days
Derivation Cohort: MSOT thresholds
Derive MSOT thresholds using histology as a reference: receiver operating characteristics (ROC) analysis to distinguish histologic active disease from remission.
Time frame: 9-10 months
Derivation Cohort: MSOT performance, diagnostic accuracy measures
Diagnostic accuracy measures (area under curve (AUC), sensitivity, specificity) of MSOT to distinguish endoscopic active disease from remission.
Time frame: 9-10 months
Derivation Cohort: MSOT performance, diagnostic accuracy
Diagnostic accuracy of MSOT to distinguish histologic active disease from remission
Time frame: 9-10 months
Validation Cohort: MSOT performance, diagnostic accuracy measures
Further diagnostic accuracy measures (sensitivity, specificity, predictive values) of MSOT to distinguish endoscopic active disease from remission using the MSOT thresholds from the derivation cohort
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Centro per la Ricerca e la Cura delle Malattie Infiammatorie Croniche Intestinali IRCCS Humanitas
Rozzano, Lombardy, Italy
I.R.C.C.S.San Raffaele, Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60
Milan, Italy
Time frame: through study completion, an average of 1 year
Validation Cohort: MSOT performance, diagnostic accuracy
Diagnostic accuracy (area under curve (AUC), sensitivity, specificity, predictive values) of MSOT to distinguish histologic active disease from remission using the MSOT thresholds from the derivation cohort.
Time frame: through study completion, an average of 1 year
Both cohorts: diagnostic accuracy
Diagnostic accuracy of MSOT to distinguish clinical active disease from remission.
Time frame: through study completion, an average of 1 year
Both cohorts: performance of other non-invasive diagnostic modalities
Assess performance of other non-invasive diagnostic modalities in order to allow for comparison to MSOT performance. Diagnostic accuracy of each of the various non-invasive tests (CRP, fCal, US, MRI) with respect to the endoscopy (reference test) and histology will be calculated using standard techniques for diagnostic studies. This includes cross tabulation of the index test results by the results of the reference standard, as well as plots of their distribution and ROC curves. Area under the Curve (AUC) estimates and confidence intervals (DeLong) will be calculated. Score confidence intervals (Wilson) will be calculated for proportions such as sensitivity, specificity, and predictive values at the predefined thresholds.
Time frame: through study completion, an average of 1 year
Both cohorts: likelihood ratios and predictive values for active inflammation
Assess the likelihood ratios and predictive values for active inflammation after MSOT examination.
Time frame: through study completion, an average of 1 year
Both cohorts: performance of MSOT in combination with other modalities
Explore performance of MSOT in combination with other modalities, e.g. in combination with ultrasound (US) or laboratory. AUC will be estimated for all non-invasive tests with a 95% confidence interval (DeLong) both from the derivation cohort and from the pooled cohorts (derivation + validation) for increased precision. Cohen's κ will be used as a measure of overall agreement. Results will be presented in three-way tables, comparing the new test (MSOT), the non-reference standard (non-invasive modalities), and the reference standard (endoscopy).
Time frame: through study completion, an average of 1 year
Both cohorts: discriminate different grades of disease activity
Investigate ability of MSOT and other non-invasive diagnostic modalities, i.e. ultrasoiund (US), fecal calprotectin (fCal), clinical scores to discriminate different grades of disease activity (remission, mild, moderate, high according to endoscopy, histology or clinical scores; for cut-offs.
Time frame: through study completion, an average of 1 year
Both cohorts: interobserver variability
Explore variations in MSOT diagnostic accuracy between sites and operators (interobserver variability).
Time frame: through study completion, an average of 1 year
Both cohorts: patient preference
Evaluate patient preference for different tests using a patient survey
Time frame: 5-10 days
Derivation cohort: MSOT thresholds using clinical scores as a reference
Derive MSOT thresholds using clinical scores as a reference: ROC analysis to distinguish clinical active disease from remission (only derivation cohort).
Time frame: through study completion, an average of 1 year