In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

• Conditions: Ulcerative Colitis

• Registration Number: NCT02852850
• Lead Sponsor: Shandong University

Brief Summary

Molecular imaging with infliximab antibody with FITC has the potential to predict therapeutic responses to infliximab antibody and can be used for personalized medicine in ulcerative colitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with active ulcerative colitis will receive infliximab antibody therapy.

Exclusion Criteria

• Patients with impaired blood clotting.
• Patients with short bowel syndrome.
• Patients during the pregnancy and lactation period.
• Patients received enema therapy within 1 month before inclusion in the study, or had anti-TNF therapy within the last 12 months.
• Patients participated in another clinical trial or administrated other investigational drugs within 4 months prior to the screening visit.
• Patients with moderate to severe heart failure, active tuberculosis or acute infections.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of specific fluorescence signal of mTNF+ cells in patients with UC	30 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China