NCT07639801Not yet recruiting
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 · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Peking University Cancer Hospital & Institute
- NCT number
- NCT07639801
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Jun 2026 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.