Evaluating the use of 18F-FDG-PET-CT for bladder cancer treatment decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how 18F-FDG-PET-CT imaging can improve the staging and treatment adaptation for patients with muscle invasive bladder cancer (MIBC). Patients will undergo two 18F-FDG-PET-CT scans to determine if they have non-metastatic, oligometastatic, or polymetastatic disease. Based on these results, treatment plans will be tailored to enhance overall survival, utilizing metastasis directed therapy or immunotherapy as appropriate. The study aims to refine risk stratification and optimize therapeutic approaches for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
* T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
* Age \> 18 years
* WHO 0-2
* Willingness to undergo 18F-FDG-PET-CT
* Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively
* Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations

Exclusion Criteria:

* Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
* Refusal of or having contraindications to 18F-FDG-PET-CT
* Refusal of MDT or immunotherapy
* Prior radiotherapy unabling MDT
* Contraindications to radiotherapy (including active inflammatory bowel disease)
* Contraindications to immunotherapy
* Other primary tumor diagnosed \< 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.

Where it's running

• Ghent University Hospital
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Valerie Fonteyne, MD; PhD — UZ Ghent
• Study coordinator: Valerie Fonteyne, MD; PhD
• Email: valerie.fonteyne@uzgent.be
• Phone: +3293323015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Assessing late images in PET-CT for bladder cancer staging

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• Neoadjuvant chemotherapy followed by watchful waiting versus immediate bladder treatment for muscle-invasive bladder cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.