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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655745
• Other study ID #: LCCC 1209
• Status: Completed
• Phase: N/A
• Start date: July 24, 2012
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 1, 2019
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• FDG PET/MR
All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Lineberger Comprehensive Cancer Center website
•   National Cancer Institute (NCI) website