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Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer (MIBC-PET)

4. august 2026 oppdatert av: University Hospital of Ferrara

Diagnostic Accuracy of 18F-FDG PET/CT in Muscle-invasive Bladder Cancer: Rationale and Design of the MIBC-PET Study

MIBC-PET is a prospective, monocentric, no-profit study with paired imaging comparison enrolling 60 patients with newly diagnosed, histologically confirmed high-grade MIBC. All patients undergo baseline staging with [18F]FDG PET/CT and contrast-enhanced CT (ceCT) of chest, abdomen, and pelvis. A second [18F]FDG PET/CT and CT are performed after two cycles of neoadjuvant therapy. [18F]FDG PET/CT includes both standard delayed imaging and an early dynamic pelvic acquisition to overcome urinary tracer interference. The primary endpoints are (1) diagnostic accuracy of [18F]FDG PET/CT versus ceCT for baseline staging, and (2) accuracy of [18F]FDG PET/CT in predicting pathological response to neoadjuvant chemotherapy. Secondary endpoints include validation of early dynamic [18F]FDG PET/CT for local staging and radiomic/AI-based predictive modeling.

Studieoversikt

Status

Rekruttering

Forhold

Muskelinvasiv blærekreft

Studietype

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Italia
- - Ferrara, Italia, 44124
    - Rekruttering
    - Azienda Ospedaliero-Universitaria di Ferrara
    - Ta kontakt med:
      
      Luca Urso, MD
      
      Telefonnummer: +390532236906
      
      E-post: luca.urso@unife.it
    - Ta kontakt med:
      
      Francesca Canella
      
      E-post: francesca.canella@ausl.fe.it

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

Ikke-sannsynlighetsprøve

Studiepopulasjon

adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC

Beskrivelse

Inclusion Criteria:

Adults aged 18 years or older Previously known oncological disease Histologically confirmed diagnosis of high-grade MIBC Non-muscle-invasive, or low-grade bladder cancer

Eligible for platinum-based neoadjuvant treatment on clinical evaluation:

ECOG performance status of 0-1,
creatinine clearance of at least 60 mL/min,
absence of comorbidities that would contraindicate chemotherapy (such as grade ≥2 neuropathy, grade ≥2 hearing impairment, or significant cardiopathy) Impossibility to perform imaging procedures, including
Claustrophobia
history of iodinated contrast medium allergy precluding ceCT
diabetes uncontrolled by medications Sign of informed consent

Exclusion Criteria:

Adults aged 18 years or older Previously known oncological disease Histologically confirmed diagnosis of high-grade MIBC Non-muscle-invasive, or low-grade bladder cancer

Eligible for platinum-based neoadjuvant treatment on clinical evaluation:

ECOG performance status of 0-1,
creatinine clearance of at least 60 mL/min,
absence of comorbidities that would contraindicate chemotherapy (such as grade ≥2 neuropathy, grade ≥2 hearing impairment, or significant cardiopathy) Impossibility to perform imaging procedures, including
Claustrophobia
history of iodinated contrast medium allergy precluding ceCT
diabetes uncontrolled by medications

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
adults with high-grade MIBC adults aged 18 years or older with a histologically confirmed diagnosis of high-grade MIBC

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Baseline Diagnostic Accuracy of [18F]FDG PET/CT in MIBC Tidsramme: At baseline, prior to initiation of neoadjuvant therapy (each cycle has a duration of 21 days)	Assessment of [18F]FDG PET/CT for initial staging of newly diagnosed muscle-invasive bladder cancer, compared with thoraco-abdomino-pelvic contrast-enhanced CT (gold standard) to determine diagnostic accuracy in defining disease extent.	At baseline, prior to initiation of neoadjuvant therapy (each cycle has a duration of 21 days)
Interim [18F]FDG PET/CT Prediction of Pathological Response Tidsramme: After 2 cycles of neoadjuvant therapy, prior to surgery (each cycle has a duration of 21 days)	Evaluation of the ability of interim [18F]FDG PET/CT to predict pathological response to neoadjuvant treatment, assessing its potential role in guiding therapeutic decision-making.	After 2 cycles of neoadjuvant therapy, prior to surgery (each cycle has a duration of 21 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital of Ferrara

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)

16. april 2024

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

23. februar 2026

Først innsendt som oppfylte QC-kriteriene

4. august 2026

Først lagt ut (Faktiske)

6. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)