RecruitingPhase 2NCT04724928

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

Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial


Sponsor

University Hospital, Ghent

Enrollment

156 participants

Start Date

Apr 29, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether using a special full-body PET-CT scan (with a radioactive sugar called FDG) helps doctors better plan treatment for patients with muscle-invasive bladder cancer — a form of bladder cancer that has grown into the muscle wall. **You may be eligible if:** - You are over 18 years old - You have been diagnosed with muscle-invasive bladder cancer confirmed by biopsy - You are planned for radical (curative) treatment - You are willing to undergo the FDG-PET-CT scan - You do not have distant metastases on standard imaging **You may NOT be eligible if:** - Your imaging already shows distant spread (metastases) - You have had prior bladder radiation - You are unwilling to undergo additional therapy (such as targeted treatment or immunotherapy) if the scan reveals spread - You have contraindications to the PET-CT scan - You have had another primary cancer within the last 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONMetastasis 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.

DRUGImmunotherapy

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.

PROCEDUREStandard 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.


Locations(1)

Ghent University Hospital

Ghent, Belgium

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NCT04724928


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