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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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. 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Matthew I. Milowsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina

Authority:

United States: Institutional Review Board

Study ID:

LCCC 1209

NCT ID:

NCT01655745

Start Date:

August 2012

Completion Date:

August 2019

Related Keywords:

  • Bladder Cancer
  • [18F]
  • Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging
  • FDG-PET-MRI
  • Muscle-Invasive Bladder Cancer
  • Pilot Study
  • LCCC 1209
  • UNC Lineberger
  • MDCT
  • Urinary Bladder Neoplasms

Name

Location
Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599-7305