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

NCT ID: NCT01655745

Last Updated: 2019-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-24
• Study Completion Date: 2019-02-01

Brief 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.

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FDG PET/MR, No Chemotherapy Arm

Patients that are NOT receiving chemotherapy but are only completing surgical intervention.

Group Type: EXPERIMENTAL

FDG PET/MR

Intervention Type: PROCEDURE

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

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).

Group Type: EXPERIMENTAL

FDG PET/MR

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Fluorodeoxyglucose Positron Emission Tomography MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew I. Milowsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/

Lineberger Comprehensive Cancer Center website

http://www.cancer.gov/

National Cancer Institute (NCI) website

Other Identifiers

LCCC 1209

Identifier Type: -

Identifier Source: org_study_id