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In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852850
Recruitment Status : Unknown
Verified October 2016 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
First Posted : August 2, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, 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.

Condition or disease
Ulcerative Colitis

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Vivo Molecular Imaging With Infliximab Antibody With FITC Predicts Therapeutic Response in Ulcerative Colitis
Study Start Date : January 2016
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. The number of specific fluorescence signal of mTNF+ cells in patients with UC [ Time Frame: 30 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with active ulcerative colitis will receive infliximab antibody therapy.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852850


Contacts
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Contact: Yanqing Li, PhD. MD. 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, PhD. MD.    18678827666    qiluliyanqing@gmail.com   
Sponsors and Collaborators
Shandong University
Investigators
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Study Director: Yanqing Li, MD,PHD Qilu Hospital of Shandong University
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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02852850    
Other Study ID Numbers: 2016SDU-QILU-12
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases