Use of PET-CT in the Management of Crohn's Disease

This study is currently recruiting participants.
Verified January 2013 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Arun Swaminath, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01182467
First received: August 12, 2010
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depending on disease severity and complications. Our purpose will be to study how PET-CT scans can be used to better manage Crohn's Disease.


Condition Intervention
Crohn's Disease
Radiation: PET-CT scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study in the Use of Positron Emission Tomography-Computed Tomography (PET-CT)in the Management of Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • To assess the correlation between PET activity and CDAI score. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To determine whether baseline PET SUV-max correlates with response to biologic therapy, as measure by CDAI.


Estimated Enrollment: 10
Study Start Date: August 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Crohn's disease Radiation: PET-CT scan
PET-CT scan performed at baseline to determine SUV-max
Other Name: Positron emission tomography-computed tomography

Detailed Description:

Crohn's disease (CD) is a gastrointestinal autoimmune disease thought to result from exposure to luminal antigen. This exposure then results in a robust Th1 mediated immune response which is not downregulated, resulting in intestinal tissue injury. Crohn's disease most commonly involves the distal small intestine, a site that can be difficult to visualize given its central location within the gastrointestinal tract.

A substantial proportion of patients do not respond to any of the standard therapies. Over 40% of patients do not respond to an initial anti-TNF (biologic) agent and approximately 10% per year lose their response to these drugs. There is no standard definition of what constitutes a patient who has primary biologic failure.

Disease activity is measured by indices such as the Crohn's Disease Activity Index (CDAI). The CDAI includes a combination of clinical criteria and lab values. However, the CDAI is limited by reliance on subjective criteria, limiting the score's use as a valid measure of studying response to medical therapy. Clinically, reliance on CDAI can result in inappropriate continuation of an ineffective therapy resulting in worsening of underlying disease, and increasing risk of adverse reactions.

Small studies have demonstrated that PET scans may accurately quantify disease activity in Crohn's. We propose to study CD patients with active flares to assess for a correlation between PET activity and CDAI. Additionally, we will determine whether PET signal intensity is predictive of clinical response to therapy with biologic agents.

The study proposes to test the hypothesis that PET can be used to determine which CD patients with small bowel disease will be true responders (or nonresponders) to biologic therapy at week 12. The use of PET to determine response to biologic therapy in small bowel Crohn's disease would be novel.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adults between ages of 21-65 who have previously been diagnosed with Crohn's disease

Criteria

Inclusion Criteria:

  • Diagnosis of Crohn's disease
  • CDAI1>220
  • Identification of small bowel disease based on an imaging study (CT scan, Abdominal ultrasound, MRI), colonoscopy, or histopathology 4. Need for initiation of biologic therapy to control disease process.

Exclusion Criteria:

  • Abdominal surgery within 8 wks of study entry
  • Change in dose of steroids or immunomodulators within 2wks of study entry
  • Pregnancy
  • Active bacterial infection or undrained abscess
  • Any contraindications to initiation of AntiTNF therapy (i.e. latent tuberculosis).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182467

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kendra Blanco    212-304-5606    kjb2170@columbia.edu   
Principal Investigator: Arun Swaminath, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Arun Swaminath, MD Columbia University
Principal Investigator: Masanori Ichise, MD Columbia University
  More Information

No publications provided

Responsible Party: Arun Swaminath, MD, Assistant Professor of Clinical Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01182467     History of Changes
Other Study ID Numbers: AAAE8300
Study First Received: August 12, 2010
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Inflammatory bowel disease, PET scan, Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014