1. To evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD2.To optimize the acquisition and reconstruction methodology and identifying simplistic uptake measurements for FAPi PET/CT for detecting and…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Visual and quantitative 68Ga-FAPi uptake measurements in the terminal ileum
and colon on baseline PET/CT of stricturing Crohn*s disease patients compared
to bowel reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging
studies in patients not suffering from IBD (when signed informed consent
available).
2. Visual and quantitative 68Ga-FAPi uptake measurements in the terminal ileum
and colon on baseline PET/CT of ulcerative colitis patients compared to bowel
reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in
patients not suffering from IBD (when signed informed consent available).
Secondary outcome
1. 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).
2. To define optimal (single and/or dual) time point(s) post injection for
imaging FAP activity in Crohn*s disease and ulcerative colitis.
3. Determine the minimal tracer injection dose required to have comparable
disease detection performance on PET as to the full tracer injection dose PET.
Exploratory endpoint:
To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds
to conventional imaging modalities and FAP protein and transcriptome expression
levels.
Background summary
Intestinal fibrosis is a complication that is frequently seen in Inflammatory
Bowel Disease (IBD) patients. At present, no anti-fibrotic treatments have been
analysed in patients suffering from IBD. Of note, outcome measures to determine
and quantify intestinal fibrosis in vivo are lacking, which hampers the
development of potential anti-fibrotic molecules.
The 68Ga-fibroblast activation protein inhibitor (FAPI) PET-CT scan is a
promising diagnostic tool for the visualisation of in vivo fibrosis and
fibrogenesis in patients with active fibrosis due to chronic inflammation. This
imaging modality targets Fibroblast Activation Protein alpha (FAPα) which has
been reported to overexpressed in fibrosis. However, there is currently limited
data of FAP imaging in chronic inflammatory diseases such as IBD and the
potential it holds to be used for disease monitoring.
Study objective
1. To evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal
fibrosis in patients with IBD
2.To optimize the acquisition and reconstruction methodology and identifying
simplistic uptake measurements for FAPi PET/CT for detecting and measuring
intestinal fibrosis.
Study design
Single-centre, pilot visibility imaging study
Study burden and risks
The burden of study participation is low. No evident health-related risks have
been identified during prior studies with the 68Ga-FAPi PET/CT scanning. It is
well tolerated but does require longer preparation compared to other
conventional imaging modalities. The estimated total radiation burden per
68Ga-FAPi-PET/ldCT scan per patient will be up to 4.1 mSv .
The additional risk of this scan for patients is the intravenous access cannula
for 68Ga-FAPi administration; which could give a local hematoma or run
subcutaneously. The risks of all before mentioned complications are minimized
by involving the department of Anesthesiology to insert these arterial
cannulations. Patients will receive standard of care as determined by their
attending physician. IUS will be performed at location AMC and is a
well-tolerated and non-invasive diagnostic tool. Patients will also have to
travel to the imaging centre to undergo a FAPi-scan at location VUMC. We expect
that our study procedures will inflict limited additional burden to the
subjects.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
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) - 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)
Exclusion criteria
- Pregnancy
- Unable to provide informed consent
- IBD-related surgeries less than 5 years ago in medical history
- Colorectal cancer
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-002751-19-NL |
| CCMO | NL82160.029.22 |