Enhancing Ultrasound & Photoacoustic for Recognition of Intestinal Abnormalities

NCT04456400 | Terminated

• 1 other identifier: cMSOT-2
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 6

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

Conditions

Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Keywords

IBD; UC; CD

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  5-10 days

Secondary Outcomes (13)

• Derivation Cohort: MSOT thresholds

  9-10 months

• Derivation Cohort: MSOT performance, diagnostic accuracy measures

  9-10 months

• Derivation Cohort: MSOT performance, diagnostic accuracy

  9-10 months

• Validation Cohort: MSOT performance, diagnostic accuracy measures

  through study completion, an average of 1 year

• Validation Cohort: MSOT performance, diagnostic accuracy

  through study completion, an average of 1 year

Study Arms (2)

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)

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)

Interventions

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.

Derivation cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed diagnosis of CD or UC in whom endoscopy is indicated

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• iThera Medical GmbH: lead
• European Commission: collaborator

Study Sites (6)

Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30

Berlin, 12203, Germany

Location

Universitätsklinikum Erlangen Medizinische Klinik 1

Erlangen, 91054, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Centro per la Ricerca e la Cura delle Malattie Infiammatorie Croniche Intestinali IRCCS Humanitas

Rozzano, Lombardy, 20133, Italy

Location

I.R.C.C.S.San Raffaele, Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60

Milan, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endoscopic histology

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Maximilian Waldner, Prof. Dr.

  Universitätsklinikum Erlangen Medizinische Klinik 1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: July 2, 2020
• Study Start: February 3, 2021
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

IT (3); DE (3)