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NCT01759017 · ClinicalTrials.gov registry record
PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease
A clinical trial, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- 8
- Enrollment target
NCT01759017: Clinical Trial study, sponsored by Brigham and Women's Hospital.
NCT01759017 is a clinical trial that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01759017 was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-01 |
Why NCT01759017 stopped before completion
NCT01759017 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01759017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01759017 about?
NCT01759017 is a clinical study titled "PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease". 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 ski...
What is the current status of trial NCT01759017?
This trial is currently terminated. The enrollment target is 8 participants. The study started on 2012-12. Estimated completion is 2015-01.
Who is sponsoring clinical trial NCT01759017?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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