Endometrial Cancer, FAPI, Hepatocellular Carcinoma, Ovarian Cancer, Prostate Cancer, PSMA, Solid Tumors
Conditions
Brief summary
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.
Interventions
RADIATION68Ga-FAPI-PSMA
Participants will receive an intravenous injection of the investigational PET tracer 68Ga-FAPI-PSMA (0.1-0.15 mCi/kg). Whole-body PET/CT imaging will be performed approximately 1 hour after injection. Delayed imaging at 2-4 hours may be performed when necessary. Imaging results will be used to evaluate tracer uptake in tumor lesions and to assess the diagnostic performance of the dual-targeted tracer.
RADIATION68Ga-PSMA-617
Participants will receive an intravenous injection of the PET tracer 68Ga-PSMA-617 (0.1-0.15 mCi/kg) followed by PET/CT imaging approximately 1 hour after administration. This imaging serves as a comparator to evaluate the diagnostic performance of the investigational tracer 68Ga-FAPI-PSMA.
RADIATION68Ga-FAPI-04
Participants may undergo PET/CT imaging using the PET tracer 68Ga-FAPI-04 (0.1-0.15 mCi/kg) with imaging performed approximately 1 hour after injection. This imaging will serve as a comparator for assessing the diagnostic performance of 68Ga-FAPI-PSMA PET/CT.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value (SUV) of Tumor Lesions | 1-4 hours after injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor-to-Background Ratio (TBR) of Target Tumor Lesions on 68Ga-FAPI-PSMA PET/CT | 1-4 hours after 68Ga-FAPI-PSMA injection | The tumor-to-background ratio (TBR) will be calculated as the SUVmax of the target tumor lesion divided by the SUVmean of the corresponding background normal tissue. TBR will be used to quantitatively assess lesion contrast on 68Ga-FAPI-PSMA PET/CT. |
| Mean Standardized Uptake Value (SUVmean) of Normal Organs on 68Ga-FAPI-PSMA PET/CT | 1 to 4 hours after 68Ga-FAPI-PSMA injection | The mean standardized uptake value (SUVmean) of normal organs and tissues, including but not limited to the liver, spleen, kidneys, lungs, bone marrow, muscle, and blood pool, will be measured on 68Ga-FAPI-PSMA PET/CT images to characterize tracer biodistribution. |
| Number of Metastatic Lesions Detected by 68Ga-FAPI-PSMA PET/CT | From the date of 68Ga-FAPI-PSMA PET/CT imaging to completion of reference-standard assessment, up to 2 months | The number of metastatic lesions detected by 68Ga-FAPI-PSMA PET/CT will be recorded for each participant. Lesion detection will be compared with standard PET tracers, including 68Ga-PSMA-617 or 68Ga-FAPI-04, when available, and/or with conventional imaging or pathological findings according to the study protocol. |
Contacts
CONTACTyifei pei
Outcome results
None listed