68Ga-FAPI-PSMA PET Imaging for the Diagnosis of Solid Tumors

June 6, 2026 updated by: Hua Zhu, Peking University Cancer Hospital & Institute

Evaluation of Dual-Targeted 68Ga-FAPI-PSMA PET/CT for the Diagnosis and Staging of Solid Tumors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-FAPI-PSMA PET/CT Imaging
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.
Radiation: 68Ga-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.
Radiation: 68Ga-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.
Radiation: 68Ga-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Uptake Value (SUV) of Tumor Lesions
Time Frame: 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.
1-4 hours after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-to-Background Ratio (TBR) of Target Tumor Lesions on 68Ga-FAPI-PSMA PET/CT
Time Frame: 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.
1-4 hours after 68Ga-FAPI-PSMA injection
Mean Standardized Uptake Value (SUVmean) of Normal Organs on 68Ga-FAPI-PSMA PET/CT
Time Frame: 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.
1 to 4 hours after 68Ga-FAPI-PSMA injection
Number of Metastatic Lesions Detected by 68Ga-FAPI-PSMA PET/CT
Time Frame: 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.
From the date of 68Ga-FAPI-PSMA PET/CT imaging to completion of reference-standard assessment, up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023KT107-ZY02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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