IBD (Inflammatory Bowel Disease)Phase 2PIMAFINCT06604260
FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
A Phase 2 study testing 68Ga-FAPi-46 in people with IBD (Inflammatory Bowel Disease) and Crohn Disease (CD), run by Dalia Lartey at 1 site in Netherlands.
Trial summary
Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- 68Ga-FAPi-46
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Aug 2023to 31 Dec 2024
- 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
- Group 1
- Adults ≥18 years with confirmed diagnosis of Crohn's disease
- AND one of the following:
- Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
- Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
- Active disease confiremed by endoscopy ( endoscopic SES-CD score \>3)
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- Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2
- Adults ≥18 years with confirmed diagnosis of ulcerative colitis
- AND one of the following:
- Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or
- Active disease confirmed by intestinal ultrasound (BWT \> 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)
- Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
Who cannot join
- Pregnancy
- Unable to provide informed consent
- IBD-related surgeries \< 5 years in medical history
- Colorectal carcinoma
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081 BT
About this study
Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.
- Being tested
- 68Ga-FAPi-46
- Keywords
- FAPI, fibroblast activation protein, FAP, FAPi-scan, 68Ga-FAPi PET-CT
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPi-46Diagnostic test
Also called FAPi-scan
68Ga FAPi PET-CT scan
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Experimental | Ulcerative colitis and Crohn's disease patients Receives: Diagnostic Test: 68Ga-FAPi-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
Measured: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
Measured: At baseline up to week 12 of study enrolment
Secondary outcomes (3)
Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi
Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn's disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available).
Measured: At baseline up to week 12 of study enrolment
Protocol optimisation
To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn's disease and ulcerative colitis.
Measured: At baseline up to week 12 of study enrolment
Minimal tracer injection dose
Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET.
Measured: At baseline up to week 12 of study enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia Lartey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dalia Lartey, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Mark Lowenberg, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604260
- Sponsor's protocol ID
- NL82160.029.22
- Other IDs
- 2022-002751-19
- Acronym
- PIMAFI
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT06604260
- Acronym / sponsor ID
- PIMAFI / NL82160.029.22
- Keywords
- FAPI, fibroblast activation protein, FAP, FAPi-scan, 68Ga-FAPi PET-CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dalia LarteyUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | Experimental | Diagnostic Test: 68Ga-FAPi-46Ulcerative colitis and Crohn's disease patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Group 1
- Adults ≥18 years with confirmed diagnosis of Crohn's disease
- Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
- Increased CRP (\>5 mg/L) and/or fecal calprotectin levels (\>250 mg/kg)
- Active disease confiremed by endoscopy ( endoscopic SES-CD score \>3)
Key exclusion criteria (4 listed)
- Pregnancy
- Unable to provide informed consent
- IBD-related surgeries \< 5 years in medical history
- Colorectal carcinoma
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 |
|---|---|---|
| 68Ga-FAPi-46Also: FAPi-scan68Ga FAPi PET-CT scan | Diagnostic test | IBD patients |
Primary outcome
Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
Time frame: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients
Time frame: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
3 secondary outcomes
Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi
Time frame: At baseline up to week 12 of study enrolment
Protocol optimisation
Time frame: At baseline up to week 12 of study enrolment
Minimal tracer injection dose
Time frame: At baseline up to week 12 of study enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Mark Lowenberg, MD PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAPi-46 in people with IBD (Inflammatory Bowel Disease) and Crohn Disease (CD), run by Dalia Lartey at 1 site in Netherlands.
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 12 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 19 Sep 2024. 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 Netherlands. 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.
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 Dalia A Lartey, MD (+31205668160, d.a.lartey@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients (time frame: At baseline up to week 12 of study enrolment). The study lists 2 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 19 Sep 2024.