NCT04724928RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 15 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 21 Jan 2021
- Start date
- 29 Apr 2021
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Bladder cancer
- NCT number
- NCT04724928
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 156
- From 29 Apr 2021 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refusal of MDT or immunotherapy
- Prior radiotherapy unabling MDT
- Contraindications to immunotherapy
Other illness
- Contraindications to radiotherapy (including active inflammatory bowel disease)
Age
- 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.
Other
- Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- Refusal of or having contraindications to 18F-FDG-PET-CT
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.