In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

Shandong University

Status: Unknown

Conditions: Ulcerative Colitis

Study type: Observational

Funder types: Other

Identifiers

NCT02852850

2016SDU-QILU-12

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Molecular Imaging With IFX-FITC

Description:

Endoscopic examination with the fluorescent antibody (IFX-FITC) was performed in patients with active ulcerative colitis before infliximab therapy was initiated. Labeled infliximab was applied topically via a standard spray catheter onto the most inflamed region of the bowel during colonoscopy, followed by CLE. In vivo imaging of inflamed areas of the intestinal mucosa showed a specific fluorescence signal of mTNF+ cells after topical application of labeled adalimumab. These specific fluorescence signals were recorded.