A Prospective Study on the Diagnosis of Malignant Tumors With 18F-FGIn PET/CT
16. maj 2026 opdateret af: Rusen Zhang, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Glutamine is a crucial nutrient for cancer cell growth, and its metabolism is frequently dysregulated in malignancies.
18F-FGln is a PET tracer that targets this altered glutamine metabolism.
However, there are currently limited studies on the diagnostic value of 18F-FGln PET/CT in various types of cancer.
Therefore, this prospective study was conducted to investigate the value of 18F-FGln PET/CT in patients with various types of malignant tumors.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Glutamine is the most abundant amino acid in plasma and a key metabolic fuel for cancer cells.
The process of glutaminolysis supports tumor growth by providing carbon, nitrogen, and energy.
PET imaging of glutamine flux using the radiotracer 18F-(2S,4R)-4-fluoroglutamine (18F-FGln) offers a novel approach to visualize a hallmark of cancer metabolism in vivo.
Early human trials have demonstrated the safety and feasibility of 18F-FGln PET, showing uptake in various cancer types.
More recent studies have shown its potential in specific applications, such as grading cerebral gliomas and guiding brain tumor biopsies.
However, there are currently limited studies on the diagnostic value of 18F-FGln PET/CT across a broad spectrum of cancer types.
Therefore, this prospective study was conducted to evaluate the diagnostic performance of 18F-FGln PET/CT in patients with various types of malignant tumors, using histopathological diagnosis as the gold standard.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
110
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rusen Zhang
- Telefonnummer: 0086-13642328295
- E-mail: zhangrusen2015@163.com
Undersøgelse Kontakt Backup
- Navn: HAO PENG
- Telefonnummer: 0086-13544443827
- E-mail: 1194171163@QQ.COM
Studiesteder
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-
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Guangzhou, Kina
- Rekruttering
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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Kontakt:
- Rusen Zhang
- Telefonnummer: 0086-13642328295
- E-mail: zhangrusen2015@163.com
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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
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
This study will include patients from the Affiliated Cancer Hospital & Institute of Guangzhou Medical University who underwent an 18F-FGln PET/CT scan between October 2025 and January 2028 .
Eligible participants are adult patients aged 18 to 70 years with suspected or histopathologically confirmed malignant tumors.
Patients with non-malignant lesions, pregnant women, and those with incomplete medical records or missing histopathological reference standards will be excluded.
Data will be collected by reviewing the institutional medical records and PET/CT imaging database.
Beskrivelse
Inclusion Criteria:
- Patients with clinical suspicion or exclusion of primary or recurrent malignant tumors (such as glioma of the brain, liver cancer, gastric cancer, duodenal cancer, colorectal cancer, ovarian cancer, etc., where 18F-FDG is prone to false negatives and false positives)
- Patients undergoing tumor staging or evaluating treatment effect using 18F-FDG PET/CT or 18F-FGln PET/CT to determine the most appropriate treatment strategy
- Patients without other tumor history
- Patients with good compliance, providing informed consent, and able to follow the research protocol
Exclusion Criteria:
- pregnant or lactating patients or patients under 18 years old
- the subjects and their parents or legal representatives are unable or unwilling to provide written informed consent;
- patients with poor compliance, unable to tolerate or cooperate with PET/CT examinations.
- those who have undergone gastrointestinal barium meal examination within one week;
- other situations where the investigators consider it inappropriate for the subjects to participate in this clinical trial
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patients with Malignant Tumors
Patients with suspected or histopathologically confirmed malignant tumors who underwent 18F-FGln PET/CT scan at the Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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SUVMAX
Tidsramme: Within one day after the PET/CT scan
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Xingxiang's Chinese report system automatically delineates the areas of interest.
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Within one day after the PET/CT scan
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TBR
Tidsramme: Within one day after the PET/CT scan
|
Xingxiang's Chinese report system automatically delineates the areas of interest.
|
Within one day after the PET/CT scan
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Faktiske)
20. oktober 2025
Primær færdiggørelse (Anslået)
1. august 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
16. maj 2026
Først indsendt, der opfyldte QC-kriterier
16. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2026
Sidst verificeret
1. august 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIT-2025021-02
Plan for individuelle deltagerdata (IPD)
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