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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002751-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients | Experimental | Ulcerative colitis and Crohn's disease patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPi-46 | Diagnostic Test | 68Ga FAPi PET-CT scan |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | At baseline up to week 12 of study enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Correspondence 68Ga-FAPi bowel uptake conventional imaging modalities and cellular FAP | To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds to conventional imaging modalities and FAP protein and transcriptome expression levels. | At baseline up to week 12 of study enrolment |
Inclusion Criteria:
Group 1
- Adults ≥18 years with confirmed diagnosis of Crohn's disease
AND one of the following:
AND one of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalia A Lartey, MD | Contact | +31205668160 | d.a.lartey@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Mark Lowenberg, MD PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1081 BT | Netherlands |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 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. | 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. | At baseline up to week 12 of study enrolment |
| D003092 | Colitis |
| D003108 | Colonic Diseases |