68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors (NCT07639801) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors
20 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Standardized Uptake Value (SUV) of Tumor Lesions
Timeframe: 1-4 hours after injection
Trial details
NCT IDNCT07639801
SponsorPeking University Cancer Hospital & Institute