Actively Recruiting
PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
Led by Karolinska University Hospital · Updated on 2021-12-29
410
Participants Needed
1
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria:
-
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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Actively Recruiting
Research Team
R
Rimma Axelsson, Professor
CONTACT
S
Siri af Burén, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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