NCT05172310RecruitingPhase 1
PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
PET Imaging of Tumors in Pancreas, Bile Ducts, Stomach and Ovaries by a Novel Tracer, 68Ga-FAPI-46 = Fibroblast Activation Protein Inhibitor
Source: ClinicalTrials.gov · Last updated 29 Dec 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Cancers of the pancreas, bile ducts, stomach and ovaries are dismal diseases with most patients being diagnosed in advanced stages leading to a bad prognosis. These cancers can be difficult to diagnose and sometimes impossible to differentiate from underlying benign conditions. Establishing the correct diagnosis of primary cancer lesions and possible spread to other organs in time is pivotal for choosing the right therapy. Routinely applied staging procedures are however not always reliable. The main aim in this study is to evaluate the diagnostic accuracy of PET/CT with a novel radiotracer, FAPI, in the primary diagnosis of cancers in the pancreas, stomach and bile ducts as well as in patients with primary and recurrent epithelial ovarian cancer (EOC).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 16 Nov 2021
- Start date
- 2 Jun 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Karolinska University Hospital
- NCT number
- NCT05172310
- EudraCT number
- 2020-002568-30
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 410
- From 2 Jun 2021 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Consecutive patients scheduled for surgical removal of either a pancreatic, biliary or gastric lesion.
- \- Consecutive patients scheduled for primary surgical removal of early stage epithelial ovarian cancer (EOC), interval debulking surgery of EOC or surgical removal or tissue biopsy of recurrent EOC
- Signed informed consent.
- Common Exclusion Criteria for all study populations:
- Age ≤18 year
- Pregnancy and lactation
- Significantly reduced renal function
- Allergy to iodinated contrast media
- Subjects that for some reason are unable to exercise their own rights, such as cognitive function impairment.
- Additional Exclusion Criteria for study populations with either pancreatic-, gastric or bile duct cancer:
- Known metastatic disease
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
Related publications
- Kinetic modelling of [⁶⁸Ga]Ga-FAPI-46 PET in pancreaticobiliary lesions: distinguishing cancer from pancreatitis.Eur J Nucl Med Mol Imaging · 2026 · PMID 42086826
This page is information, not medical advice. Discuss any trial with your doctor.