A Prospective Study on the Diagnosis of Malignant Tumors With 18F-FGIn PET/CT
16. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
110
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Rusen Zhang
- Telefonnummer: 0086-13642328295
- E-post: zhangrusen2015@163.com
Studer Kontakt Backup
- Navn: HAO PENG
- Telefonnummer: 0086-13544443827
- E-post: 1194171163@QQ.COM
Studiesteder
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Guangzhou, Kina
- Rekruttering
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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Ta kontakt med:
- Rusen Zhang
- Telefonnummer: 0086-13642328295
- E-post: zhangrusen2015@163.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. oktober 2025
Primær fullføring (Antatt)
1. august 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
16. mai 2026
Først innsendt som oppfylte QC-kriteriene
16. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mai 2026
Sist bekreftet
1. august 2025
Mer informasjon
Begreper knyttet til denne studien
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .