Inflammatory Bowel DiseasesEUPHORIANCT04456400
Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by iThera Medical GmbH at 6 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Multispectral Optoacoustic Tomography (MSOT)
- How many people
- 200 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Feb 2021to 25 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed diagnosis of CD or UC in whom endoscopy is indicated
Who may be able to join
- Established diagnosis of UC or CD for at least three months prior to enrollment
- Age ≥ 18 years
- Indication for endoscopy according to institutes routine care
- Written informed consent
Who cannot join
- Stoma independent of localization, ileoanal pouch
- Prior bowel surgery other than ileocecal resection, which potentially affects the study procedure by fundamentally changing bowel anatomy by removing the ROI (e.g. (partial) resection of the sigmoid, left sided colon) or repositioning the ROI to an inaccessible location (e.g. right-sided colectomy with transversostomy)
- Indeterminate Colitis, irritable bowel syndrome (IBS)
- Involvement of the upper gastrointestinal (GI) track only
- Isolated proctitis
- Complications, such as infectious enteritis, infectious colitis and infectious enterocolitis, abscess formation, intestinal obstruction, toxic megacolon
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- Tattoo in skin area of interest
- Skin lesions, scar tissue or skin diseases affecting the area of imaging
- Highly pigmented skin in the area of imaging (e.g. Fitzpatrick skin type V and VI)
- The bowel wall is invisible in the Ultrasound image of the MSOT system
- Medication leading to increased light sensitivity
- Pregnant and breastfeeding women
- Mental retardation of the patient with restriction of general judgment and awareness
- Exclusion due to safety concerns of investigator (subject who has any condition, including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany3 sites
Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30
Berlin, 12203
Universitätsklinikum Erlangen Medizinische Klinik 1
Erlangen, 91054
Universitätsklinikum Jena
Jena, 07747
Italy3 sites
I.R.C.C.S.San Raffaele, Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60
Milan, 20132
Policlinico Tor Vergata
Rome, Lazio, 00133
Centro per la Ricerca e la Cura delle Malattie Infiammatorie Croniche Intestinali IRCCS Humanitas
Rozzano, Lombardy, 20133
About this study
Official title: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)
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
Read the detailed description
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.
- Being tested
- Multispectral Optoacoustic Tomography (MSOT)
- Keywords
- IBD, UC, CD
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic Tomography (MSOT)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Derivation cohort | The derivation sub-cohort will be used to derive optimum reconstruction algorithm parameters of MSOT images.
Primary objective of the derivation cohort is to derive Multispectral Optoacoustic Tomography (MSOT) thresholds maximizing receiver operating characteristic (ROC) to distinguish endoscopic remission from active disease.
As secondary objective, performance of the Multispectral Optoacoustic Tomography (MSOT) device will be analyzed. Receives: Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT) | |
| Validation cohort | Objective of the validation cohort is to confirm the performance of Multispectral Optoacoustic Tomography (MSOT) using prescribed thresholds from the derivation cohort. Receives: Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5-10 days
Secondary outcomes (13)
Derivation Cohort: MSOT thresholds
Derive MSOT thresholds using histology as a reference: receiver operating characteristics (ROC) analysis to distinguish histologic active disease from remission.
Measured: 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.
Measured: 9-10 months
Derivation Cohort: MSOT performance, diagnostic accuracy
Diagnostic accuracy of MSOT to distinguish histologic active disease from remission
Measured: 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
Measured: 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.
Measured: through study completion, an average of 1 year
Both cohorts: diagnostic accuracy
Diagnostic accuracy of MSOT to distinguish clinical active disease from remission.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: through study completion, an average of 1 year
Both cohorts: interobserver variability
Explore variations in MSOT diagnostic accuracy between sites and operators (interobserver variability).
Measured: through study completion, an average of 1 year
Both cohorts: patient preference
Evaluate patient preference for different tests using a patient survey
Measured: 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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start3 Feb 2021
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Why it stopped: The termination is based on a shifted commercial interest of the Sponsor and is not related to any safety grounds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- iThera Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Maximilian Waldner, Prof. Dr., Principal investigator, Universitätsklinikum Erlangen Medizinische Klinik 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456400
- Sponsor's protocol ID
- cMSOT-2
- Acronym
- EUPHORIA
- Status last verified
- Apr 2025
- First submitted
- 19 Jun 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)
- ClinicalTrials.gov ID
- NCT04456400
- Acronym / sponsor ID
- EUPHORIA / cMSOT-2
- Keywords
- IBD, UC, CD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The termination is based on a shifted commercial interest of the Sponsor and is not related to any safety grounds.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- iThera Medical GmbHIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation cohort | – | Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT)The derivation sub-cohort will be used to derive optimum reconstruction algorithm parameters of MSOT images. Primary objective of the derivation cohort is to derive Multispectral Optoacoustic Tomography (MSOT) thresholds maximizing receiver operating characteristic (ROC) to distinguish endoscopic remission from active disease. As secondary objective, performance of the Multispectral Optoacoustic Tomography (MSOT) device will be analyzed. |
| Validation cohort | – | Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT)Objective of the validation cohort is to confirm the performance of Multispectral Optoacoustic Tomography (MSOT) using prescribed thresholds from the derivation cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed diagnosis of CD or UC in whom endoscopy is indicated
Key inclusion criteria (4 listed)
- Established diagnosis of UC or CD for at least three months prior to enrollment
- Age ≥ 18 years
- Indication for endoscopy according to institutes routine care
- Written informed consent
Key exclusion criteria (14 listed)
- Stoma independent of localization, ileoanal pouch
- Prior bowel surgery other than ileocecal resection, which potentially affects the study procedure by fundamentally changing bowel anatomy by removing the ROI (e.g. (partial) resection of the sigmoid, left sided colon) or repositioning the ROI to an inaccessible location (e.g. right-sided colectomy with transversostomy)
- Indeterminate Colitis, irritable bowel syndrome (IBS)
- Involvement of the upper gastrointestinal (GI) track only
- Isolated proctitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic Tomography (MSOT)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. | Diagnostic test | Derivation cohort, Validation cohort |
Primary outcome
Derivation Cohort: derive optimum diagnostic MSOT thresholds
Time frame: 5-10 days
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.
Validation cohort: re-assess the diagnostic accuracy of MSOT
Time frame: 5-10 days
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
13 secondary outcomes
Derivation Cohort: MSOT thresholds
Time frame: 9-10 months
Derivation Cohort: MSOT performance, diagnostic accuracy measures
Time frame: 9-10 months
Derivation Cohort: MSOT performance, diagnostic accuracy
Time frame: 9-10 months
Validation Cohort: MSOT performance, diagnostic accuracy measures
Time frame: through study completion, an average of 1 year
Validation Cohort: MSOT performance, diagnostic accuracy
Time frame: through study completion, an average of 1 year
Both cohorts: diagnostic accuracy
Time frame: through study completion, an average of 1 year
Both cohorts: performance of other non-invasive diagnostic modalities
Time frame: through study completion, an average of 1 year
Both cohorts: likelihood ratios and predictive values for active inflammation
Time frame: through study completion, an average of 1 year
Both cohorts: performance of MSOT in combination with other modalities
Time frame: through study completion, an average of 1 year
Both cohorts: discriminate different grades of disease activity
Time frame: through study completion, an average of 1 year
Both cohorts: interobserver variability
Time frame: through study completion, an average of 1 year
Both cohorts: patient preference
Time frame: 5-10 days
Derivation cohort: MSOT thresholds using clinical scores as a reference
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: The termination is based on a shifted commercial interest of the Sponsor and is not related to any safety grounds.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian Waldner, Prof. Dr. principal investigator
Universitätsklinikum Erlangen Medizinische Klinik 1
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Ulcerative Colitis, run by iThera Medical GmbH at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The termination is based on a shifted commercial interest of the Sponsor and is not related to any safety grounds.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Derivation Cohort: derive optimum diagnostic MSOT thresholds (time frame: 5-10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.