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Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer

NCT04724928 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-01-15

No results posted yet for this study

Summary

Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.

Conditions

  • Muscle-Invasive Bladder Carcinoma

Interventions

RADIATION

Metastasis directed therapy (MDT)

Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Concurrently, the oligometastasis will be treated with stereotactic body radiotherapy or metastasectomy.

DRUG

Immunotherapy

Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards immunotherapy will be initiated and regular follow up will be performed.

PROCEDURE

Standard of care

Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards regular follow up is performed.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Valerie Fonteyne, MD; PhD · UZ Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2029-12-31
Completion
2030-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724928 on ClinicalTrials.gov