Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer

Study Overview
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Brief Summary
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This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer.

Detailed Description
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This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer. All patients will undergo baseline FDG-PET-MRI and routine (standard of care) contrast enhanced abdominal/pelvic multi-detector computed tomography (MDCT). The imaging results will ultimately be compared to final pathology as the gold standard. If the accuracy of FDG-PET-MRI is improved as compared to standard MDCT, the investigators plan to conduct a larger follow-up study to confirm the results of this pilot study. In addition, this pilot study will set the stage for the evaluation of novel PET tracers in the imaging of bladder cancer.

Official Title
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LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: FDG PET/MR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age (no upper age limit) Informed consent obtained and signed cT2/T3-N0-M0 urothelial carcinoma of the bladder Planned radical cystectomy with pelvic lymph node dissection No known local regional or distant metastatic disease Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI Exclusion Criteria: History of severe reaction to contrast-enhanced CT scan Poorly controlled diabetes mellitus Inability to tolerate PET and/or MRI Presence of pacemaker or intracranial aneurysm clip Serum creatinine >1.8 mg/dL OR GFR < 30mL/min Pregnant or lactating female Inability to lie flat for >1 hour Body Mass Index (BMI) >35 History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDG PET/MR, No Chemotherapy Arm<br>Patients that are NOT receiving chemotherapy but are only completing surgical intervention. | Procedure: FDG PET/MR<br>* All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection<br>* Other names: Fluorodeoxyglucose Positron Emission Tomography MRI;|
| Experimental: FDG PET/MR, Chemotherapy Arm<br>Patients that are receiving chemotherapy prior to completing surgical intervention. These patients will receive a FDG PET/MR prior to chemotherapy and after completion of chemotherapy (at the time of pre-op, before surgical intervention). | Procedure: FDG PET/MR<br>* All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection<br>* Other names: Fluorodeoxyglucose Positron Emission Tomography MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer | The sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder will be evaluated by using the pathology from the radical cystectomy and lymph node dissection specimen or biopsy as the reference standard. The sensitivity and specificity of FDG-PET-MRI will be compared to conventional CT performed in all patients in this pilot study and FDG-PET-CT. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of FDG-PET-MRI with RFS, DSS and OS in patients with muscle-invasive bladder cancer | A positive FDG-PET-MRI or routine contrast enhanced abdominal/pelvic MDCT will be defined as evidence of metastatic disease as follows: 1) regionally, in the pelvic lymph nodes; or 2) distantly, to bone, lung, viscera or lymph nodes outside of the pelvis. OS will be defined as the time from the PET-MRI to the date of death from any cause. DSS will be defined from the date of PET-MRI to the date of death from disease. RFS will be defined as the time from the date of PET-MRI to recurrence or death from disease. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[18F], FDG Positron Emission Tomography-Magnetic Resonance Imaging, FDG-PET-MRI, Muscle-Invasive Bladder Cancer, Pilot Study, LCCC 1209, UNC Lineberger, MDCT