PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease
Stopped early
Conditions studied: Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT01759017
- Run by
- Brigham and Women's Hospital
- People needed
- 8
- Starts
- 2012-12-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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