Clinical trial · Interventional
68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
A Prospective Study to Evaluate 68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
- 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)
Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with epithelial ovarian cancer who are scheduled for surgical intervention. The findings of 68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in evaluating EOC, and histological findings.
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 |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epithelial ovarian cancer
- description
- 68Ga-FAPI-04 and 18F-FDG PET/CT
- interventionNames
- Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Primary outcomes (1)
- measure
- SUVmax of positive lesions
- timeFrame
- 1 hour after tracer injection
- description
- 68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax
Secondary outcomes (1)
- measure
- Histological findings
- timeFrame
- 60 day after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent signed * EOC patients who are scheduled for surgery. The diagnosis of EOC should be based on the previous histological results or cytological evaluation combined with a serum CA-125 to carcinoembryonic antigen ratio\>25 to confirm the primary diagnosis and exclude a nongynecologic cancer. Exclusion Criteria: * Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI-04. * Tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. * Pregnant or breast-feeding women. * Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
References
Publications (0)
Data not yet available