Clinical trial · Interventional
68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors
Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET/CT for the Diagnosis and Staging of Solid Tumors
- 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)
This study aims to evaluate a novel dual-targeted PET imaging tracer, 68Ga-FAPI-PSMA, for the detection and evaluation of solid tumors. Fibroblast activation protein (FAP) and prostate-specific membrane antigen (PSMA) are two important molecular targets that are highly expressed in tumor cells or the tumor microenvironment. Combining these two targets into a single imaging probe may improve the sensitivity and accuracy of tumor detection. In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-FAPI-PSMA. The imaging results will be compared with standard PET tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-FAPI-PSMA PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| FAPI | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSMA | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-04 | Radiation | — | UNRESOLVED |
| 68Ga-FAPI-PSMA | Radiation | — | UNRESOLVED |
| 68Ga-PSMA-617 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI-PSMA PET/CT Imaging
- description
- Participants with suspected or confirmed solid tumors will undergo PET/CT imaging using the investigational tracer 68Ga-FAPI-PSMA. Imaging findings will be compared with PET/CT performed using standard tracers such as 68Ga-PSMA-617 or 68Ga-FAPI-04 to evaluate the diagnostic performance of the dual-targeted tracer.
- interventionNames
- Radiation: 68Ga-FAPI-PSMA
- Radiation: 68Ga-PSMA-617
- Radiation: 68Ga-FAPI-04
Primary outcomes (1)
- measure
- Standardized Uptake Value (SUV) of Tumor Lesions
- timeFrame
- 1-4 hours after injection
- description
- The standardized uptake value (SUV) of target or suspected tumor lesions measured on 68Ga-FAPI-PSMA PET/CT imaging. SUV values will be used to evaluate tracer uptake and diagnostic performance in solid tumors.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75 years * Patients with suspected or confirmed solid tumors (e.g., prostate cancer, hepatocellular carcinoma, ovarian cancer, or endometrial cancer) * Patients scheduled to undergo tumor biopsy or surgical treatment within 2 months * ECOG performance status of 0 or 1 * Expected survival of at least 12 weeks * Adequate hematologic and organ function: * White blood cell count ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L * Platelet count ≥ 100 × 10\^9/L * Hemoglobin ≥ 90 g/L * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * ALT/AST ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases) * Creatinine ≤ 1.5 × ULN * At least one measurable lesion according to RECIST 1.1 criteria * Ability to understand the study procedures and willingness to sign written informed consent Exclusion Criteria: * Severe hepatic or renal dysfunction * Inability to remain in a supine position for approximately 30 minutes during PET/CT scanning * Refusal or inability to participate in the clinical study * Claustrophobia or severe psychiatric disorders that would interfere with imaging procedures * Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study
References
Publications (0)
Data not yet available