Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04724928

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

Led by University Hospital, Ghent · Updated on 2025-01-15

156

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

K

Kom Op Tegen Kanker

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathology-proven muscle-invasive bladder cancer on TURb or stage 3 on conventional imaging treated with radical treatment
  • T1-4 N0-3 M0 muscle-invasive bladder cancer on conventional thoracic CT and abdominopelvic CT/MRI
  • Age greater than 18 years
  • WHO performance status 0-2
  • Willingness to undergo 18F-FDG-PET-CT scanning
  • Willingness to undergo metastasis-directed therapy or immunotherapy if diagnosed with oligometastatic or polymetastatic disease
  • Ability to provide signed informed consent according to ICH/GCP and local regulations
Not Eligible

You will not qualify if you...

  • Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/MRI)
  • Refusal or contraindications to 18F-FDG-PET-CT
  • Refusal of metastasis-directed therapy or immunotherapy
  • Prior radiotherapy preventing metastasis-directed therapy
  • Contraindications to radiotherapy including active inflammatory bowel disease
  • Contraindications to immunotherapy
  • Other primary tumor diagnosed less than 5 years ago requiring treatment except non-metastatic prostate cancer or non-melanoma skin cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

V

Valerie Fonteyne, MD; PhD

CONTACT

F

Flor Verghote, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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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 | DecenTrialz