- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07925125
Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions
Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis, and early detection of pancreatic lesions is of great importance for improving patient outcomes. In this study, whole-body imaging with FDG and FAPI will be used to visualize the early development of pancreatic cancer lesions from multiple perspectives, including glucose metabolism, tumor fibrotic stroma, and integrin receptor expression. Furthermore, leveraging the advantages of four-dimensional dynamic long-axial PET imaging, artificial intelligence-assisted lesion detection and analysis will be performed to characterize lesions and differentiate between benign and malignant lesions. The imaging findings will subsequently be compared with postoperative histopathological results to evaluate the diagnostic performance of the proposed imaging approaches.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Li
- Telefonnummer: 0086-021-64370045
- E-post: lb10363@rjh.com.cn
Studiesteder
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-
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Shanghai, Kina, 200025
- Rekruttering
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Ta kontakt med:
- Li
- Telefonnummer: 0086-021-64370045
- E-post: lb10363@rjh.com.cn
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients with suspected pancreatic tumors treated at Ruijin Hospital
Beskrivelse
Inclusion Criteria:
- Patients with suspected pancreatic tumors larger than 1.0 cm.
- No histopathological diagnosis available before enrollment.
- No prior treatment for the suspected pancreatic tumor.
- Histopathological diagnosis obtained through surgery or biopsy within 2 months after PET imaging.
- Able and willing to provide written informed consent.
- Willing and able to comply with the study procedures and follow-up requirements.
- Male or female, aged 18-75 years.
- In generally good health, with an estimated life expectancy of more than 6 months and able to tolerate the imaging procedures.
Exclusion Criteria:
- Severe concomitant diseases that, in the investigator's judgment, make participation in the study inappropriate, including severe cardiopulmonary dysfunction or severe hepatic or renal impairment.
- Pregnancy, suspected pregnancy, or breastfeeding.
- Poor compliance with the study procedures.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Patients with Suspected Pancreatic Lesions
Participants with suspected pancreatic lesions undergoing PET imaging will be enrolled in this prospective observational study. Imaging approaches may include FDG and FAPI PET, with four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted lesion detection and characterization. Imaging findings will be evaluated for lesion detection and benign-malignant differentiation and compared with postoperative histopathological results when available. |
Routine PET imaging performed as part of clinical care will be evaluated in this prospective observational study. Four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted image analysis will be used for pancreatic lesion detection and characterization, including differentiation between benign and malignant lesions. Imaging findings will be compared with histopathological results when available. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization
Tidsramme: Within 2 months after PET imaging
|
The diagnostic performance of 4D dynamic long-axial PET imaging combined with artificial intelligence-assisted lesion detection and analysis will be evaluated for the detection and differentiation of benign and malignant pancreatic lesions. Imaging findings will be compared with postoperative histopathological results as the reference standard |
Within 2 months after PET imaging
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Neoplasmer i endokrine kjertel
- Pankreassykdommer
- Neoplasmer i bukspyttkjertelen
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Tomografi
- Diagnostisk avbildning
- Radiografi
- Bildetolkning, datamaskinassistert
- Radiografisk bildeforbedring
- Bildeforbedring
- Fotografi
- Tomografi, røntgen
- Tomografi, emisjon-beregnet
- Radionuklidavbildning
- Diagnostiske teknikker, radioisotop
- Positron-emisjonstomografi
- Tomografi, røntgenberegnet
- Multimodal avbildning
- Positron emission tomography computertomography
Andre studie-ID-numre
- RuijinH 2024(338)
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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