Status:

NOT_YET_RECRUITING

Safety and Feasibility of Immuno-OCT

Lead Sponsor:

University Medical Center Groningen

Conditions:

Colon Carcinoma

Barrett Esophagus

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The...

Eligibility Criteria

Inclusion

  • Indication for a therapeutic endoscopy procedure (EMR or ESD);
  • Age ≥ 18;
  • Written informed consent.

Exclusion

  • Patients younger than 18 years old;
  • Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);
  • Radiation therapy for esophageal or colorectal cancer;
  • History of infusion reactions to Bevacizumab or other monoclonal antibodies;
  • Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;
  • Non-adjustable hypertension;
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
  • Pregnancy or breastfeeding; a negative pregnancy test must be available for women of childbearing potential.

Key Trial Info

Start Date :

April 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2025

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT06008522

Start Date

April 1 2024

End Date

March 1 2025

Last Update

March 20 2024

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