In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

NCT02852850 | Unknown DMC

• 1 other identifier: 2016SDU-QILU-12
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• The number of specific fluorescence signal of mTNF+ cells in patients with UC

  30 months

Study Arms (1)

Molecular Imaging With IFX-FITC

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active ulcerative colitis will receive infliximab antibody therapy.

You may qualify if:

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

You may not qualify if:

• Patients with impaired blood clotting.
• Patients with short bowel syndrome.
• Patients during the pregnancy and lactation period.
• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanqing Li, MD,PHD

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yanqing Li, PhD. MD.

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

CN (1)