PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorKarolinska University Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consecutive patients scheduled for surgical removal of either a pancreatic, biliary or gastric lesion.
Signed informed consent.
Disqualifiers
Age ≤18 year
Pregnancy and lactation
Significantly reduced renal function
Allergy to iodinated contrast media
Trial design
Design model
Parallel
Treatments tested in this trial
68Ga-FAPI-46
Drug* \[68Ga\] Ga-FAPI-46 Solution for Injection is manufactured at the Karolinska University Hospital Radiopharmacy facilities, for imaging studies with Positron Emission Tomography (PET). * It is a radiolabelled Fibroblast Activation Protein Inhibitor (FAPI) used for PET of a number of different cancer entities. * Depending on the labelling yield 50 - 370 megabecquerel (MBq) of \[68Ga\] Ga-FAPI-46 Solution for Injection will be administered intravenously 60 minutes prior to whole-body PET image acquisition.
PET/CT
Device* Combined PET and computed tomography (CT) imaging with 68Ga-FAPI-46 will be performed using the same protocol on a "Biograph 6" PET/CT scanner (Siemens, Erlangen, Germany) and "General Electrics" (GE) Discovery 710, Milwaukee, Wisconsin, USA at the Department of Nuclear Medicine, Karolinska Huddinge within 2 weeks before surgery. * PET/CT imaging will be performed in dynamic mode at one bed position centered over the primary tumor for 45 minutes. * At 60 minutes post injection, a whole-body PET will be acquired.
Treatment groups
410 Participants
are divided into 2 treatment groupsGroup A: Cancer patientsExperimental treatment 2 interventions
Group B: Non cancer patientsActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of FAPI-PET/CT in primary tumors
To validate the proportion of false-positive and false-negative FAPI-PET/CT findings in primary pancreas, biliary and gastric tumors as well as in primary and recurrent EOC with postsurgical or true cut biopsy histopathological confirmation of diagnosis (PAD) as a reference standard
Time frame
up to 18 monthsSecondary outcomes
1
Diagnostic accuracy of FAPI-PET/CT in metastases
To validate the proportion of false-positive and false-negative FAPI-PET/CT findings in resected metastatic tumor tissue/resected lymph nodes, in primary (and recurrent for EOC) tumors, by using postsurgical tissue samples or biopsies as well as PAD as a reference standard.
Time frame
up to 18 months2
Immunohistochemistry
To investigate the correlation between in-vivo uptake of FAPI and ex-vivo immunohistochemically determined biomarker expression in the stroma of these tumors (both benign and malignant) with PAD as a reference standard
Time frame
up to 18 months3
FAPI-PET/CT and stroma markers as prognostic factors for Disease Free Survival (DFS)
Disease Free Survival (DFS) at 1-year, 2-years and 5-years clinical follow-ups.
Time frame
up to 5 years4
FAPI-PET/CT and stroma markers as prognostic factors for Overall Survival (OS)
Overall Survival (OS) at 1-year, 2-years and 5-years clinical follow-ups.
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov