Clinical trial NCT04456400: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities
Official title: Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Keywords: IBD
UC
CD
Lead sponsor: iThera Medical GmbH
Sponsor class: INDUSTRY
Collaborators: name: European Commission
First posted: 2020-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of CD or UC in whom endoscopy is indicated

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

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.

Eligibility 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)

Primary outcomes:
measure: Derivation Cohort: derive optimum diagnostic MSOT thresholds
timeFrame: 5-10 days
measure: Validation cohort: re-assess the diagnostic accuracy of MSOT
timeFrame: 5-10 days
Secondary outcomes:
measure: Derivation Cohort: MSOT thresholds
timeFrame: 9-10 months
measure: Derivation Cohort: MSOT performance, diagnostic accuracy measures
timeFrame: 9-10 months
measure: Derivation Cohort: MSOT performance, diagnostic accuracy
timeFrame: 9-10 months
measure: Validation Cohort: MSOT performance, diagnostic accuracy measures
timeFrame: through study completion, an average of 1 year
measure: Validation Cohort: MSOT performance, diagnostic accuracy
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: diagnostic accuracy
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: performance of other non-invasive diagnostic modalities
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: likelihood ratios and predictive values for active inflammation
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: performance of MSOT in combination with other modalities
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: discriminate different grades of disease activity
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: interobserver variability
timeFrame: through study completion, an average of 1 year
measure: Both cohorts: patient preference
timeFrame: 5-10 days
measure: Derivation cohort: MSOT thresholds using clinical scores as a reference
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen Medizinische Klinik 1
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Roma
country: Italy
facility: Policlinico Tor Vergata
state: Lazio
city: Rozzano
country: Italy
facility: Centro per la Ricerca e la Cura delle Malattie Infiammatorie Croniche Intestinali IRCCS Humanitas
state: Lombardia
city: Milan
country: Italy
facility: I.R.C.C.S.San Raffaele, Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60
Study officials:
affiliation: Universitätsklinikum Erlangen Medizinische Klinik 1
name: Maximilian Waldner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: