Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer
NCT ID: NCT04724928
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
156 participants
INTERVENTIONAL
2021-04-29
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-metastatic MIBC
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's
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.
Oligo-metastatic MIBC on 18F-FDG-PET-CT
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's
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.
Poly-metastatic MIBC on 18F-FDG-PET-CT
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of \> 3 metastasis on 1 or both 18F FDG PET-CT 's
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Kom Op Tegen Kanker
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Valerie Fonteyne, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Verghote F, Poppe L, Verbeke S, Dirix P, Albersen M, De Meerleer G, Berghen C, Ost P, Villeirs G, De Visschere P, De Man K, De Maeseneer D, Rottey S, Van Praet C, Decaestecker K, Fonteyne V. 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. BMC Cancer. 2021 Oct 18;21(1):1113. doi: 10.1186/s12885-021-08861-x.
Other Identifiers
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BC-07456
Identifier Type: OTHER
Identifier Source: secondary_id
BC-07456
Identifier Type: -
Identifier Source: org_study_id
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