Actively Recruiting
Led by University Hospital, Ghent · Updated on 2025-01-15
156
Participants Needed
1
Research Sites
17 weeks
Total Duration
U
University Hospital, Ghent
Lead Sponsor
K
Kom Op Tegen Kanker
Collaborating Sponsor
Researchers are evaluating how 18F-FDG-PET-CT scans affect the staging and treatment plans for patients with muscle invasive bladder cancer (MIBC). This phase II trial aims to improve overall survival by using these scans to classify patients into non-metastatic, oligometastatic, or polymetastatic groups and adapting treatment based on this risk stratification. The study is sponsored by University Hospital, Ghent and focuses on adults with confirmed MIBC. Participants receive standard care involving either radical cystectomy with pelvic lymph node removal or a combination of tumor resection and radiochemotherapy. Depending on the PET-CT results, patients with oligometastatic disease may receive metastasis directed therapy like targeted radiotherapy or surgery, while those with polymetastatic disease may be given immunotherapy after standard treatment. Patients without extra-pelvic metastasis continue with standard care and follow-up. The study does not use randomization or blinding. During the study, patients undergo two 18F-FDG-PET-CT scans to assess metastasis, alongside conventional imaging. Researchers monitor various outcomes including overall survival at two years, toxicity at three months and five years, progression-free survival, and quality of life over five years using questionnaires. Additional assessments include biomarker validation and measuring the accuracy of PET-CT in detecting metastases. Participants are followed closely with regular check-ups and monitoring throughout the study period ending in May 2030.
CONDITIONS
Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies depending on treatment plan
Participants receive standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (complete TURb and radio chemotherapy). Those diagnosed with oligometastatic disease receive metastasis directed therapy including stereotactic body radiotherapy or metastasectomy. Participants with polymetastatic disease may receive immunotherapy following standard therapy.
Multiple visits during treatment period for therapy administration and monitoring
Duration - Up to 5 years
After completing treatment, participants undergo regular follow-up to monitor for disease progression, survival, and quality of life.
Regular follow-up visits over several years
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
V
Valerie Fonteyne, MD; PhD
F
Flor Verghote, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Flor Verghote, Lindsay Poppe, Sofie Verbeke...
https://pubmed.ncbi.nlm.nih.gov/34663254