In Vivo Molecular Imaging Predicts Therapeutic Response in Ulcerative Colitis

NCT ID: NCT02852850

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD,PHD

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, PhD. MD.

Role: CONTACT

86-531-82169236

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

18678827666

Other Identifiers

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2016SDU-QILU-12

Identifier Type: -

Identifier Source: org_study_id

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