PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease

NCT01759017 | Terminated

• 2 other identifiers: 2012P000570BWH2012P000570
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The costs and potential complications (side effects) of therapies currently used to treat Crohn's disease could be reduced if a non-invasive test existed that determined which therapies benefit patients and which do not. A non-invasive test is a test that does not involve cutting or entering the skin. Currently, once therapies are prescribed, doctors rely solely on clinical parameters to gauge whether the therapies are helpful. This includes evaluation of overall general well-being, abdominal pain, and number of liquid stools per day. There is no established and reliable non-invasive test that can predict whether a person is responding to therapy early in the course of treatment when these evaluations may be inconclusive. During this research study we will look for changes in sugar metabolism on low-dose PET/CT before and 2 weeks after the first infusion of infliximab therapy. This is to find out if these changes can predict clinical response and steroid-free remission at two, six and 12 months, in patients with Crohn's disease.

Conditions

Crohn's Disease

Keywords

Crohn's disease; Inflammatory bowel disease; IBD; Infliximab; PET; PET/CT

Outcome Measures

Primary Outcomes (1)

• Decrease in bowel FDG-uptake from enrollment to 2 weeks

  Low-dose PET/CT will be performed at enrollment and at 2 weeks. Patients will be categorized as infliximab responders or non-responders based on clinical measures (overall assessment by the patient's gastroenterologist, Harvey-Bradshaw Index score, and any Crohn's-related hospitalization or surgery). We will determine if the decrease in bowel FDG-uptake is significantly different between responders and non-responders.

  one year

Secondary Outcomes (1)

• Determination of the optimal threshold for decrease in FDG uptake on PET/CT for predicting clinical response

  one year

Study Arms (2)

Infliximab responders

Gastroenterologist's overall assessment (response) Decrease in Harvey-Bradshaw index score of 2 or more points (clinical response) Harvey-Bradshaw index score less than 5 (clinical remission) Maintenance of steroid-free remission No Crohn's-related hospitalizations or surgeries

Infliximab non-responders

Gastroenterologist's overall assessment (no response) Decrease in Harvey-Bradshaw index score of 1 or 0 points, or increase in HBI (no response) Harvey-Bradshaw index score greater than or equal to 5 (no remission) Resumption of steroid treatment Crohn's-related hospitalization or surgery

Eligibility Criteria

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

Study Population

Adult patients with a new diagnosis of symptomatic Crohn's disease or an established diagnosis of Crohn's disease with suspected flare. The diagnosis of Crohn's disease will be based on the combination of clinical, imaging, endoscopic, and pathology findings.

You may qualify if:

• New diagnosis of symptomatic Crohn's disease or an established diagnosis of Crohn's disease with a suspected flare.
• Appropriate clinical candidate for infliximab induction therapy, as determined by the patient's gastroenterologist

You may not qualify if:

• Anti-TNF medications in the previous 6 months
• Pregnancy or plan to become pregnant
• Severe claustrophobia, sufficient to preclude PET/CT scanning

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Shyn PB, Mortele KJ, Britz-Cunningham SH, Friedman S, Odze RD, Burakoff R, Goldberg JE, Erturk M, Silverman SG. Low-dose 18F-FDG PET/CT enterography: improving on CT enterography assessment of patients with Crohn disease. J Nucl Med. 2010 Dec;51(12):1841-8. doi: 10.2967/jnumed.110.080796. Epub 2010 Nov 15.

  PMID: 21078803 BACKGROUND

• Shyn PB. 18F-FDG positron emission tomography: potential utility in the assessment of Crohn's disease. Abdom Imaging. 2012 Jun;37(3):377-86. doi: 10.1007/s00261-011-9793-y.

  PMID: 21833729 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Paul B Shyn, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 2, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

US (1)