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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG PET/MR
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring [18F], FDG Positron Emission Tomography-Magnetic Resonance Imaging, FDG-PET-MRI, Muscle-Invasive Bladder Cancer, Pilot Study, LCCC 1209, UNC Lineberger, MDCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FDG PET/MR, No Chemotherapy Arm

FDG PET/MR, Chemotherapy Arm

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 26, 2012
Last Updated
October 30, 2019
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01655745
Brief Title
Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 24, 2012 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
[18F], FDG Positron Emission Tomography-Magnetic Resonance Imaging, FDG-PET-MRI, Muscle-Invasive Bladder Cancer, Pilot Study, LCCC 1209, UNC Lineberger, MDCT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDG PET/MR, No Chemotherapy Arm
Arm Type
Experimental
Arm Description
Patients that are NOT receiving chemotherapy but are only completing surgical intervention.
Arm Title
FDG PET/MR, Chemotherapy Arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
FDG PET/MR
Other Intervention Name(s)
Fluorodeoxyglucose Positron Emission Tomography MRI
Intervention Description
All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection
Primary Outcome Measure Information:
Title
Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Association of FDG-PET-MRI with RFS, DSS and OS in patients with muscle-invasive bladder cancer
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew I. Milowsky, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Links:
URL
http://unclineberger.org/
Description
Lineberger Comprehensive Cancer Center website
URL
http://www.cancer.gov/
Description
National Cancer Institute (NCI) website

Learn more about this trial

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

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