Clinical trial NCT01759017: PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease
Official title: Molecular Imaging to Predict Response to Infliximab Therapy in Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Keywords: Crohn's disease
Inflammatory bowel disease
IBD
Infliximab
PET
PET/CT
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The costs and potential complications (side effects) of therapies currently used to treat Crohn's disease could potentially be reduced if a non-invasive test existed that determined which therapies benefit patients and which do not. 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.

PET/CT can be used to detect active inflammation (reaction of a part of the body to injury or infection) in Crohn's disease as well as complications such as ulcers, fissures, and strictures (thinning of, breaks in, and fixed narrowing of the bowel, respectively). PET (positron emission tomography) scans take pictures using special dyes that "light up" inside the body. This happens because the special dyes contain radiation, which is similar to the radiation in a standard x-ray. CT (computed tomography) uses x-rays and a computer to make pictures.

The radioactive tracer that will be used in this study is FDG. FDG is a radioactive sugar. FDG is approved by the U.S. Food and Drug Administration (FDA). This tracer can show early response to chemotherapy or other cancer treatments for a variety of tumors. Changes in FDG uptake accurately predict persistent response in as little as hours to days after therapy has begun. These changes often happen weeks to months before anatomic changes on CT or MRI. Sometimes the CT or MRI never changes.

One of the few FDG PET studies looking at treatment for an inflammatory condition showed that FDG uptake decreased significantly within two weeks of starting therapy for rheumatoid arthritis. Accurate early assessment with FDG PET/CT shortly after starting therapy with infliximab has the potential to change the standard clinical approach to both initial and continuing infliximab therapy in patients with Crohn's disease.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Decrease in bowel FDG-uptake from enrollment to 2 weeks
timeFrame: one year
Secondary outcomes:
measure: Determination of the optimal threshold for decrease in FDG uptake on PET/CT for predicting clinical response
timeFrame: one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Paul B Shyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.