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.

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