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

iThera Medical

Status: Terminated

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04456400

cMSOT-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

200 participants in 2 patient groups

Derivation cohort

Description:

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.

Treatment:

Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT)

Validation cohort

Description:

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

Treatment:

Diagnostic Test: Multispectral Optoacoustic Tomography (MSOT)