- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655745
Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer
October 30, 2019 updated by: UNC Lineberger Comprehensive Cancer Center
LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive Bladder Cancer
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Lineberger Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: FDG PET/MR, No Chemotherapy Arm
Patients that are NOT receiving chemotherapy but are only completing surgical intervention.
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All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection
Other Names:
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EXPERIMENTAL: FDG PET/MR, Chemotherapy Arm
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).
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All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
Time Frame: 3 years
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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.
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3 years
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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
Time Frame: 3 years
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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.
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthew I. Milowsky, MD, University of North Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 24, 2012
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
February 1, 2019
Study Registration Dates
First Submitted
July 26, 2012
First Submitted That Met QC Criteria
August 1, 2012
First Posted (ESTIMATE)
August 2, 2012
Study Record Updates
Last Update Posted (ACTUAL)
October 31, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC 1209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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