PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
NCT ID: NCT05172310
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
410 participants
INTERVENTIONAL
2021-06-02
2029-03-31
Brief Summary
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Detailed Description
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The Fibroblast Activation Protein (FAP) is one of the more prominent stroma markers and was the focus in the development of an agent for imaging and, eventually, even targeted radionuclide therapy. FAP is a type II membrane bound glycoprotein absent or only expressed at insignificant levels, in normal tissues in adults. The FAP inhibitor, FAPI, gets selectively enriched in tissues where its target protein is expressed and there is no or very limited FAPI uptake in all normal organs. This opens new possibilities for the detection of malignant lesions with higher stromal content based on the high contrast positron emission tomography (PET) images obtained with a 68-Gallium (68Ga) radiolabeled - FAPI compound. As cancers in pancreas, stomach, bile ducts and ovaries are all characterized by abundant desmoplasia that constitutes up to 90% of the total tumor volume and contains extracellular matrix, immune cells, vasculature and CAFs, it would be suitable for targeted imaging with FAPI.
Preliminary studies show elevated FAPI uptake in many tumors rich in fibroblasts along with low background uptake. The main objective of this prospective study is to improve non-invasive diagnostics of malignancy in tumors of pancreas, stomach, bile ducts and ovaries, all known for a strong desmoplastic reaction by evaluating the diagnostic accuracy of PET/CT with a novel radiotracer, FAPI in the primary diagnosis and staging of such cancers.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
* surgical removal of either a malignant lesion in the pancreas, bile ducts, or stomach (first arm)
* surgical removal of primary stage epithelial cancer of the ovary (EOC), interval debulking surgery (IDS) of EOC or surgical removal/tissue biopsy of recurrent EOC (first arm)
* surgical removal of a benign lesion in the pancreas (second arm)
All patients will undergo a PET/CT with the interventional drug/radiotracer 68Ga-FAPI-46 before surgery.
DIAGNOSTIC
NONE
Study Groups
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Cancer patients
* Adults with suspected cancer of either pancreas, bile ducts or stomach
* Adults with primary and recurrent epithelial ovarian cancer (EOC)
68Ga-FAPI-46
* \[68Ga\] 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
* 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.
Non cancer patients
Non cancer patients operated for non-malignant diseases in pancreas during the same period of time will be investigated with the same procedure.
68Ga-FAPI-46
* \[68Ga\] 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
* 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.
Interventions
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68Ga-FAPI-46
* \[68Ga\] 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
* 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.
Eligibility Criteria
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Inclusion Criteria
\- 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.
Exclusion Criteria
* 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.
• Known metastatic disease
19 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Rimma Axelsson
Professor
Principal Investigators
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Rimma Axelsson, Professor
Role: PRINCIPAL_INVESTIGATOR
Medical Radiation Physics and Nuclear Medicine, Karolinska University Hospital
Locations
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Karolinska University Hospital Huddinge
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Rimma Axelsson, Professor
Role: primary
Siri af Burén, MD
Role: backup
References
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Other Identifiers
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2020-002568-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H035-FAPI
Identifier Type: -
Identifier Source: org_study_id