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

Crohn's Disease Clinical Trial

Official title:

Molecular Imaging to Predict Response to Infliximab Therapy in Patients With Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01759017
• Other study ID #: 2012P000570
• Secondary ID: BWH2012P000570
• Status: Terminated
• Phase: N/A
• First received: December 21, 2012
• Last updated: July 20, 2015
• Start date: December 2012
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Determination of the optimal threshold for decrease in FDG uptake on PET/CT for predicting clinical response	Using ROC analysis, we will determine the optimal threshold to separate patients classified as infliximab responders or non-responders for Crohn's disease.	one year	No