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DETOUR; Determining the safety and feasibility of optical coherence tomography and near infrared fluorescence: a prospective pilot intervention study

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506395-27-00
Enrollment
15
Registered
2024-01-22
Start date
2024-03-15
Completion date
Unknown
Last updated
2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus, Colon carcinoma, gastrointestinal dysplasia

Brief summary

Safety evaluation of immuno-OCT imaging: Number of adverse device-related events (ADE’s) and serious adverse device-related events (SADE’s)., Feasibility of in vivo immuno-OCT imaging and interpretation of the in vivo immuno-OCT results

Detailed description

Validation of the immuno-OCT endoscopy results compared to: Fluorescence seen in FME imaging results; The correlation of ex vivo fluorescent signals to histopathological analysis results; The correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results;

Interventions

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Safety evaluation of immuno-OCT imaging: Number of adverse device-related events (ADE’s) and serious adverse device-related events (SADE’s)., Feasibility of in vivo immuno-OCT imaging and interpretation of the in vivo immuno-OCT results

Secondary

MeasureTime frame
Validation of the immuno-OCT endoscopy results compared to: Fluorescence seen in FME imaging results; The correlation of ex vivo fluorescent signals to histopathological analysis results; The correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results;

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026