Clinical trial · Interventional
Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging in Malignant Tumors
Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging
- 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)
Positron emission tomography (PET) molecular imaging provides a valuable tool for the diagnosis and differential diagnosis, staging of various tumors. Malignant tumor is composed of tumor cells and tumor stroma, which occupies the vast majority of the tumor. Cancer-associated fibroblasts (CAF) are an important part of the tumor stroma. Fibroblast activation protein (FAP) is over-expressed in CAF, which is closely related to tumor growth, invasion, metastasis, immunosuppression and prognosis; and the expression level of FAP in normal tissues and organs is very low. So it becomes an excellent target for cancer diagnosis and treatment. Radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that specifically target to FAP as a tracer for PET imaging can be applied for targeted diagnosis and treatment of cancer. Recently, some studies have found that gallium-68 (68Ga) -FAPI as a new novel positron tracer has shown to be with good application potential. In this prospective study, the investigators will use integrated PET/MR, and PET/CT with the agent 68Ga-FAPI and conventional imaging agent \[F-18\] fluorodeoxyglucose (18F-FDG) to diagnose and stage various cancers, the aim is to make up for the deficiency in FDG PET imaging in the diagnosis and staging of some cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTA-FAPI | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
| PET/MR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTA-FAPI PET/MR
- description
- Investigators select subjects from patients with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging, focusing on malignant tumors with poor results of FDG PET/CT imaging, such as brain tumors, liver tumors, digestive system tumors and peritoneal, greater omentum, and mesenteric metastatic tumors. Patients undergo 68Ga-DOTA-FAPI PET/MR imaging within one week.
- interventionNames
- Drug: 68Ga-DOTA-FAPI
- Device: PET/MR
- Device: PET/CT
Primary outcomes (1)
- measure
- Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in some malignant tumors.
- timeFrame
- 2 years
- description
- For subjects with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging, diagnosis and staging results of 68Ga-DOTA-FAPI PET/MR, PET/CT will be compared to 18F-FDG PET/CT imaging, pathology, clinical and follow-up result.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging. * Subjects are able to understand and sign the informed consent voluntarily, with good compliance. Exclusion Criteria: * Acute systemic diseases and electrolyte disorders. * Pregnant or lactating women. * Patients refuse to sign the informed consent.
References
Publications (4)
- DERIVEDQin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3. PMID 35657428
- DERIVEDQin C, Song Y, Liu X, Gai Y, Liu Q, Ruan W, Liu F, Hu F, Lan X. Increased uptake of 68Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):709-720. doi: 10.1007/s00259-021-05472-3. Epub 2021 Jul 9. PMID 34241652
- DERIVEDQin C, Liu F, Huang J, Ruan W, Liu Q, Gai Y, Hu F, Jiang D, Hu Y, Yang K, Lan X. A head-to-head comparison of 68Ga-DOTA-FAPI-04 and 18F-FDG PET/MR in patients with nasopharyngeal carcinoma: a prospective study. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3228-3237. doi: 10.1007/s00259-021-05255-w. Epub 2021 Feb 20. PMID 33609152
- DERIVEDZhang X, Song W, Qin C, Liu F, Lan X. Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2635-2641. doi: 10.1007/s00259-021-05194-6. Epub 2021 Jan 15. PMID 33452634