Trials / Recruiting
RecruitingNCT04724928
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-04-29
- Primary completion
- 2029-12-31
- Completion
- 2030-05-01
- First posted
- 2021-01-26
- Last updated
- 2025-01-15
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04724928. Inclusion in this directory is not an endorsement.