Crohn DiseasePhase 2NCT04502303
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
A Phase 2 study testing 18F-FDG and 68Ga-FAPI PET/CT in people with Crohn Disease, run by Peking Union Medical College Hospital.
Trial summary
Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the result of chronic transmural inflammation combined with a dysregulated wound-healing process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- 18F-FDG and 68Ga-FAPI PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Sep 2021
- Phase
- Phase 2
- 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
Who may be able to join
- Written informed consent signed
- Crohn's disease patients with proofs of intestine stricture by other modalities, e.g. MRI, CT, ultrasound, and/or endoscopy.
Who cannot join
- Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI.
- If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake.
- Pregnant or breast-feeding women.
- Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT
Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the result of chronic transmural inflammation combined with a dysregulated wound-healing process. While inflammatory strictures may respond to anti-inflammatory treatment, fibrotic strictures are usually anti-inflammation resistant, requiring further endoscopic balloon dilation or surgical intervention. Therefore, to determinate the inflammatory or fibrotic nature of intestinal stricture is a key step in the treatment of CD. 18F-FDG is a radiotracer reflecting the glucose metabolism of disease and is usually accumulated in inflammatory disease. 68Ga-FAPI is a novel radiotracer that specifically targets fibroblast activation protein (FAP). FAP is a membrane glycoprotein expressed on activated fibroblasts, which are key cells in the process of fibrotic intestinal stricture of CD. In this study, we hypothesis that the inflammatory or fibrotic nature of intestinal stricture can be non-invasively evaluated by 18F-FDG and 68Ga-FAPI PET/CT in patients with CD.
Read the detailed description
Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consectutive days. The accumulation of 18F-FDG and 68Ga-FAPI at the site of stricture will be determined by standard uptake value (SUV), molecular volume (MV), and total molecular index (TMI). In patients with a planned surgical resection of one or more stricture (s), the image results will be compared with histological findings.
- Conditions
- Crohn Disease
- Being tested
- 18F-FDG and 68Ga-FAPI PET/CT
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG and 68Ga-FAPI PET/CTDiagnostic test
Participants will undergo 18F-FDG (0.12-0.15mCi/kg) and 68Ga-FAPI (3-6mCi) PET/CT on two consecutive days. At least 6 hours of fast is required for 18F-FDG PET scan, while no dietary control is necessary for 68Ga-FAPI PET scan. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. If the patient is planned for surgical resection of one or more stricture (s), the scans have to be completed within a maximum period of 30 days before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease: patients with intestinal stricture | Experimental | Patients with intestinal strictures confirmed by other modalities, e.g. CT, MR, ultrasound, and endoscopy, will be recruited in the study. Receives: Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax of stenotic intestine
The SUVmax of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the highest extent of inflammation and fibrosis, respectively.
Measured: Day 30 after PET scan
MV of stenotic intestine
The MV of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the involved area of inflammation and fibrosis, respectively.
Measured: Day 30 after PET scan
TMI of stenotic intestine
The TMI of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the overall extent of inflammation and fibrosis, respectively.
Measured: Day 30 after PET scan
Secondary outcomes (1)
Histological findings
In patients with surgical resection of stenotic intestine, the extent of inflammation and fibrosis will be determined.
Measured: Day 90 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consecutive days.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502303
- Sponsor's protocol ID
- FAPICD
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT
- ClinicalTrials.gov ID
- NCT04502303
- Acronym / sponsor ID
- FAPICD
- Conditions
- Crohn Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Aug 2020 (actual)
- 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.
Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the result of chronic transmural inflammation combined with a dysregulated wound-healing process. While inflammatory strictures may respond to anti-inflammatory treatment, fibrotic strictures are usually anti-inflammation resistant, requiring further endoscopic balloon dilation or surgical intervention. Therefore, to determinate the inflammatory or fibrotic nature of intestinal stricture is a key step in the treatment of CD. 18F-FDG is a radiotracer reflecting the glucose metabolism of disease and is usually accumulated in inflammatory disease. 68Ga-FAPI is a novel radiotracer that specifically targets fibroblast activation protein (FAP). FAP is a membrane glycoprotein expressed on activated fibroblasts, which are key cells in the process of fibrotic intestinal stricture of CD. In this study, we hypothesis that the inflammatory or fibrotic nature of intestinal stricture can be non-invasively evaluated by 18F-FDG and 68Ga-FAPI PET/CT in patients with CD.
Detailed description
Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consectutive days. The accumulation of 18F-FDG and 68Ga-FAPI at the site of stricture will be determined by standard uptake value (SUV), molecular volume (MV), and total molecular index (TMI). In patients with a planned surgical resection of one or more stricture (s), the image results will be compared with histological findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease: patients with intestinal stricture | Experimental | Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CTPatients with intestinal strictures confirmed by other modalities, e.g. CT, MR, ultrasound, and endoscopy, will be recruited in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent signed
- Crohn's disease patients with proofs of intestine stricture by other modalities, e.g. MRI, CT, ultrasound, and/or endoscopy.
Key exclusion criteria (4 listed)
- Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI.
- If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake.
- Pregnant or breast-feeding women.
- Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG and 68Ga-FAPI PET/CTParticipants will undergo 18F-FDG (0.12-0.15mCi/kg) and 68Ga-FAPI (3-6mCi) PET/CT on two consecutive days. At least 6 hours of fast is required for 18F-FDG PET scan, while no dietary control is necessary for 68Ga-FAPI PET scan. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. If the patient is planned for surgical resection of one or more stricture (s), the scans have to be completed within a maximum period of 30 days before the surgery. | Diagnostic test | Crohn's disease: patients with intestinal stricture |
Primary outcome
SUVmax of stenotic intestine
Time frame: Day 30 after PET scan
The SUVmax of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the highest extent of inflammation and fibrosis, respectively.
MV of stenotic intestine
Time frame: Day 30 after PET scan
The MV of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the involved area of inflammation and fibrosis, respectively.
TMI of stenotic intestine
Time frame: Day 30 after PET scan
The TMI of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the overall extent of inflammation and fibrosis, respectively.
1 secondary outcome
Histological findings
Time frame: Day 90 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FDG and 68Ga-FAPI PET/CT in people with Crohn Disease, run by Peking Union Medical College Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjia Zhu, MD (+86 18614080164, zhuwenjia_pumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax of stenotic intestine (time frame: Day 30 after PET scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2020.