Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Neoplasms | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-46 | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cancer patients
- description
- * Adults with suspected cancer of either pancreas, bile ducts or stomach * Adults with primary and recurrent epithelial ovarian cancer (EOC)
- interventionNames
- Drug: 68Ga-FAPI-46
- Device: PET/CT
- type
- ACTIVE_COMPARATOR
- label
- Non cancer patients
- description
- Non cancer patients operated for non-malignant diseases in pancreas during the same period of time will be investigated with the same procedure.
- interventionNames
- Drug: 68Ga-FAPI-46
- Device: PET/CT
Primary outcomes (1)
- measure
- Diagnostic accuracy of FAPI-PET/CT in primary tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (41)
- BACKGROUNDDavidson B, Goldberg I, Kopolovic J. Inflammatory response in cervical intraepithelial neoplasia and squamous cell carcinoma of the uterine cervix. Pathol Res Pract. 1997;193(7):491-5. doi: 10.1016/s0344-0338(97)80102-1. PMID 9342755
- BACKGROUNDWhatcott CJ, Posner RG, Von Hoff DD, Han H. Desmoplasia and chemoresistance in pancreatic cancer. In: Grippo PJ, Munshi HG, editors. Pancreatic Cancer and Tumor Microenvironment. Trivandrum (India): Transworld Research Network; 2012. Chapter 8. Available from http://www.ncbi.nlm.nih.gov/books/NBK98939/ PMID 22876390
- BACKGROUNDMoon SB, Hur JM, Koo HH, Suh YL, Shin HB, Seo JM, Lee SK. Desmoplastic small round cell tumor of the stomach mimicking a gastric cancer in a child. J Korean Surg Soc. 2011 Jun;80 Suppl 1(Suppl 1):S80-4. doi: 10.4174/jkss.2011.80.Suppl1.S80. Epub 2011 Jun 17. PMID 22066092
- BACKGROUNDBaba AI, Câtoi C. TUMORS OF THE ALIMENTARY SYSTEM [Internet]. The Publishing House of the Romanian Academy; 2007 [cited 2020 Apr 1]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK9565/
- BACKGROUNDFiori ME, Di Franco S, Villanova L, Bianca P, Stassi G, De Maria R. Cancer-associated fibroblasts as abettors of tumor progression at the crossroads of EMT and therapy resistance. Mol Cancer. 2019 Mar 30;18(1):70. doi: 10.1186/s12943-019-0994-2. PMID 30927908
- BACKGROUNDHam IH, Lee D, Hur H. Role of Cancer-Associated Fibroblast in Gastric Cancer Progression and Resistance to Treatments. J Oncol. 2019 Jun 9;2019:6270784. doi: 10.1155/2019/6270784. eCollection 2019. PMID 31281359
- BACKGROUNDMa Y, Zhu J, Chen S, Li T, Ma J, Guo S, Hu J, Yue T, Zhang J, Wang P, Wang X, Chen G, Liu Y. Activated gastric cancer-associated fibroblasts contribute to the malignant phenotype and 5-FU resistance via paracrine action in gastric cancer. Cancer Cell Int. 2018 Jul 20;18:104. doi: 10.1186/s12935-018-0599-7. eCollection 2018.