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

6. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Stråling: 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.
Stråling: 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.
Stråling: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Standardized Uptake Value (SUV) of Tumor Lesions
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tumor-to-Background Ratio (TBR) of Target Tumor Lesions on 68Ga-FAPI-PSMA PET/CT
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University Cancer Hospital & Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

2. april 2026

Først indsendt, der opfyldte QC-kriterier

6. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023KT107-ZY02

Plan for individuelle deltagerdata (IPD)

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INGEN

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