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NCT Number: NCT07639801

68Ga-FAPI-PSMA PET Imaging for the Diagnosis 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.

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Key information

Conditions

Prostate Cancer Adenocarcinoma Adnexal Diseases Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms FAPI Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms PSMA Prostatic Diseases Prostatic Neoplasms Solid Tumors Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-FAPI-PSMA

Radiation

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.

68Ga-PSMA-617

Radiation

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.

68Ga-FAPI-04

Radiation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

yifei pei

CONTACT

[email protected]

+86 15602222734

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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