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

NCT07639801 | Not Yet Recruiting DMC

• 1 other identifier: 2023KT107-ZY02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer; Hepatocellular Carcinoma; Ovarian Cancer; Solid Tumors; Endometrial Cancer; FAPI; PSMA

Outcome Measures

Primary Outcomes (1)

• Standardized Uptake Value (SUV) of Tumor Lesions

  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 Outcomes (3)

• Tumor-to-Background Ratio (TBR) of Target Tumor Lesions 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

  1 to 4 hours after 68Ga-FAPI-PSMA injection

• 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

Study Arms (1)

68Ga-FAPI-PSMA PET/CT Imaging

EXPERIMENTAL

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; Radiation: 68Ga-PSMA-617; Radiation: 68Ga-FAPI-04

Interventions

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-FAPI-PSMA PET/CT Imaging

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-PSMA PET/CT Imaging

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.

68Ga-FAPI-PSMA PET/CT Imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Carcinoma, Hepatocellular; Ovarian Neoplasms; Endometrial Neoplasms

Interventions

68Ga-FAPI

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Central Study Contacts

yifei pei

CONTACT

+86 15602222734; peiyfiei0523@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share