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Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)

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ClinicalTrials.gov Identifier: NCT04456400
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : June 28, 2022
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
iThera Medical GmbH

Brief 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 patients
  • Prepare a study protocol for large-scale clinical validation study in inflammatory bowel disease (IBD)
  • Successfully execute the clinical validation study

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT)

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.

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Study Type : Observational
Estimated Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Diagnostic Test: 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.

Validation cohort
Objective of the validation cohort is to confirm the performance of Multispectral Optoacoustic Tomography (MSOT) using prescribed thresholds from the derivation cohort.
Diagnostic Test: 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.




Primary Outcome Measures :
  1. 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.

  2. 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



Secondary Outcome Measures :
  1. Derivation Cohort: MSOT thresholds [ Time Frame: 9-10 months ]
    Derive MSOT thresholds using histology as a reference: receiver operating characteristics (ROC) analysis to distinguish histologic active disease from remission.

  2. Derivation Cohort: MSOT performance, diagnostic accuracy measures [ Time Frame: 9-10 months ]
    Diagnostic accuracy measures (area under curve (AUC), sensitivity, specificity) of MSOT to distinguish endoscopic active disease from remission.

  3. Derivation Cohort: MSOT performance, diagnostic accuracy [ Time Frame: 9-10 months ]
    Diagnostic accuracy of MSOT to distinguish histologic active disease from remission

  4. Validation Cohort: MSOT performance, diagnostic accuracy measures [ Time Frame: through study completion, an average of 1 year ]
    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

  5. Validation Cohort: MSOT performance, diagnostic accuracy [ Time Frame: through study completion, an average of 1 year ]
    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.

  6. Both cohorts: diagnostic accuracy [ Time Frame: through study completion, an average of 1 year ]
    Diagnostic accuracy of MSOT to distinguish clinical active disease from remission.

  7. Both cohorts: performance of other non-invasive diagnostic modalities [ Time Frame: through study completion, an average of 1 year ]
    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.

  8. Both cohorts: likelihood ratios and predictive values for active inflammation [ Time Frame: through study completion, an average of 1 year ]
    Assess the likelihood ratios and predictive values for active inflammation after MSOT examination.

  9. Both cohorts: performance of MSOT in combination with other modalities [ Time Frame: through study completion, an average of 1 year ]
    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).

  10. Both cohorts: discriminate different grades of disease activity [ Time Frame: through study completion, an average of 1 year ]
    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.

  11. Both cohorts: interobserver variability [ Time Frame: through study completion, an average of 1 year ]
    Explore variations in MSOT diagnostic accuracy between sites and operators (interobserver variability).

  12. Both cohorts: patient preference [ Time Frame: 5-10 days ]
    Evaluate patient preference for different tests using a patient survey

  13. Derivation cohort: MSOT thresholds using clinical scores as a reference [ Time Frame: through study completion, an average of 1 year ]
    Derive MSOT thresholds using clinical scores as a reference: ROC analysis to distinguish clinical active disease from remission (only derivation cohort).


Biospecimen Retention:   Samples Without DNA
Endoscopic histology


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed diagnosis of CD or UC in whom endoscopy is indicated
Criteria

Inclusion Criteria:

  1. Established diagnosis of UC or CD for at least three months prior to enrollment
  2. Age ≥ 18 years
  3. Indication for endoscopy according to institutes routine care
  4. Written informed consent

Exclusion Criteria:

  1. Stoma independent of localization, ileoanal pouch
  2. 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)
  3. Indeterminate Colitis, irritable bowel syndrome (IBS)
  4. Involvement of the upper gastrointestinal (GI) track only
  5. Isolated proctitis
  6. Complications, such as infectious enteritis, infectious colitis and infectious enterocolitis, abscess formation, intestinal obstruction, toxic megacolon
  7. Tattoo in skin area of interest
  8. Skin lesions, scar tissue or skin diseases affecting the area of imaging
  9. Highly pigmented skin in the area of imaging (e.g. Fitzpatrick skin type V and VI)
  10. The bowel wall is invisible in the Ultrasound image of the MSOT system
  11. Medication leading to increased light sensitivity
  12. Pregnant and breastfeeding women
  13. Mental retardation of the patient with restriction of general judgment and awareness
  14. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456400


Contacts
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Contact: Claudia Jendrewski, MSc +49 89 700744913 claudia.jendrewski@ithera-medical.com
Contact: Philipp Bell, Dr. rer.pol. +49 89 700744911 philipp.bell@ithera-medical.com

Locations
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Germany
Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30 Not yet recruiting
Berlin, Germany, 12203
Contact: Britta Siegmund, Prof. Dr.    +49 30 450 514 ext 342    britta.siegmund@charite.de   
Contact: Patricia Schaafs    +49 30 450 614 ext 876    patricia.schaafs@charite.de   
Universitätsklinikum Erlangen Medizinische Klinik 1 Recruiting
Erlangen, Germany, 91054
Contact: Maximilian Waldner, Prof.    +49913185 ext 35000    Maximilian.Waldner@uk-erlangen.de   
Contact: Daniel Klett, Dr. med.    +49913185 ext 35204    Daniel.Klett@uk-erlangen.de   
Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Andreas Stallmach, Prof.    +49 3641 9-324582    andreas.stallmach@med.uni-jena.de   
Contact: Philipp Grunert, Dr. med.    +49 3641 9-324582    Philip.Grunert@med.uni-jena.de   
Italy
Policlinico Tor Vergata Suspended
Roma, Lazio, Italy, 00133
Centro per la Ricerca e la Cura delle Malattie Infiammatorie Croniche Intestinali IRCCS Humanitas Not yet recruiting
Rozzano, Lombardia, Italy, 20133
Contact: Mariangela Allocca, MD, PhD    +39022643 ext 2069    ibd@hsr.it   
I.R.C.C.S.San Raffaele, Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60 Recruiting
Milan, Italy, 20132
Contact: Mariangela Allocca, Dott. ssa    +39 2264 312 069    allocca.mariangela@hsr.it   
Contact: Carmen di Matteo    +39 2264 394 94    dimatteo.carmen@hsr.it   
Sponsors and Collaborators
iThera Medical GmbH
European Commission
Investigators
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Principal Investigator: Maximilian Waldner, Prof. Dr. Universitätsklinikum Erlangen Medizinische Klinik 1
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Responsible Party: iThera Medical GmbH
ClinicalTrials.gov Identifier: NCT04456400    
Other Study ID Numbers: cMSOT-2
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by iThera Medical GmbH:
IBD
UC
CD
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases