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2021-06-02
2024-06-30
2029-03-31
410
NCT05172310
Karolinska University Hospital
Karolinska University Hospital
INTERVENTIONAL
PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI
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).
Malignant tumors exceeding 1-2 mm in size require formation of a supporting stroma, which includes vascular cells, inflammatory cells and fibroblasts . Several organs in the upper gastro-intestinal tract are known to develop tumors with strong desmoplastic reaction characterized by pervasive growth of tumor stroma. The pancreas, stomach, bile ducts and ovaries are all organs with this property. Within tumor stroma, a subpopulation of fibroblasts called cancer-associated fibroblasts (CAFs) are known to be involved in growth, migration and progression of the tumor. 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-11-16 | N/A | 2021-12-13 |
2021-12-13 | N/A | 2021-12-29 |
2021-12-29 | N/A | 2021-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cancer patients * Adults with suspected cancer of either pancreas, bile ducts or stomach * Adults with primary and recurrent epithelial ovarian cancer (EOC) | DRUG: 68Ga-FAPI-46
DEVICE: PET/CT
|
| ACTIVE_COMPARATOR: 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. | DRUG: 68Ga-FAPI-46
DEVICE: PET/CT
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | up to 18 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | up to 18 months |
| 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 | up to 18 months |
| 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. | up to 5 years |
| 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. | up to 5 years |
| Correlation between FAPI-PET/CT imaging results and those of conventional radiology | To investigate the difference in diagnostic accuracy of FAPI-PET/CT compared to conventional imaging diagnostics performed according to clinical routine, by using postsurgical PAD as a reference standard both for differentiation between malignant and benign lesions as well as for N and M staging. | up to 18 months |
| Safety of 68Ga-FAPI-46 | Frequency of * Adverse Events (AEs) * Adverse Reactions (ARs)- * Serious Adverse Events (SAEs) and * Suspected Unexpected Serious Adverse Reactions (SUSARs). | up to 1 month |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Rimma Axelsson, Professor Phone Number: +46 708 227 622 Email: rimma.axelsson@ki.se |
Study Contact Backup Name: Siri af Burén, MD Phone Number: +46-739099570 Email: siri.afburen@regionstockholm.se |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
