Crohn's DiseaseNCT01759017
PET/CT to Predict Response to Infliximab Therapy in Patients With Crohn's Disease
An observational study of Crohn's Disease, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Anti-TNF medications in the previous 6 months
- Pregnancy or plan to become pregnant
- Severe claustrophobia, sufficient to preclude PET/CT scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Molecular Imaging 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 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.
Read the 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.
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Inflammatory bowel disease, IBD, Infliximab, PET, PET/CT
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Bernard Shyn, Brigham and Women's Hospital
- Investigators
- Paul B Shyn, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759017
- Sponsor's protocol ID
- 2012P000570
- Other IDs
- BWH2012P000570
- Status last verified
- Jul 2015
- First submitted
- 21 Dec 2012
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21078803Shyn 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.
PubMed 21833729
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging to Predict Response to Infliximab Therapy in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01759017
- Acronym / sponsor ID
- 2012P000570
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Inflammatory bowel disease, IBD, Infliximab, PET, PET/CT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Anti-TNF medications in the previous 6 months
- Pregnancy or plan to become pregnant
- Severe claustrophobia, sufficient to preclude PET/CT scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decrease in bowel FDG-uptake from enrollment to 2 weeks
Time frame: one year
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.
1 secondary outcome
Determination of the optimal threshold for decrease in FDG uptake on PET/CT for predicting clinical response
Time frame: one year
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Background: PubMed 21078803Shyn 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.
- Background: PubMed 21833729Shyn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul B Shyn, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in bowel FDG-uptake from enrollment to 2 weeks (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.