SUPPORT HOTLINE (888) 901-2226
Donate Now

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

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


  • Org Study ID: LCCC 1209
  • Secondary ID:
  • NCT ID: NCT01655745
  • NCT Alias:
  • Sponsor: UNC Lineberger Comprehensive Cancer Center - Other
  • Source: UNC Lineberger Comprehensive Cancer Center

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: August 2012 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer

Primary Outcome 1 - Time Frame: 3 years

Condition:

  • Bladder Cancer

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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Matthew I. Milowsky, MD

Role: Principal Investigator

Affiliation: University of North Carolina

Overall Contact

Name: Kristine Baluyot

Phone: 919-843-5420

Email: kristine_baluyot@med.unc.edu

Link: Lineberger Comprehensive Cancer Center website

Location

Facility Status Contact
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Recruiting