NCT01655745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

4.4 years

First QC Date

July 26, 2012

Last Update Submit

October 30, 2019

Conditions

Bladder Cancer

Keywords

[18F]FDG Positron Emission Tomography-Magnetic Resonance ImagingFDG-PET-MRIMuscle-Invasive Bladder CancerPilot StudyLCCC 1209UNC LinebergerMDCT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Association of FDG-PET-MRI with RFS, DSS and OS in patients with muscle-invasive bladder cancer

    3 years

Study Arms (2)

FDG PET/MR, No Chemotherapy Arm

EXPERIMENTAL

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

Procedure: FDG PET/MR

FDG PET/MR, Chemotherapy Arm

EXPERIMENTAL

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).

Procedure: FDG PET/MR

Interventions

FDG PET/MRPROCEDURE

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

Also known as: Fluorodeoxyglucose Positron Emission Tomography MRI
FDG PET/MR, Chemotherapy ArmFDG PET/MR, No Chemotherapy Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Matthew I. Milowsky, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2012

First Posted

August 2, 2012

Study Start

July 24, 2012

Primary Completion

December 1, 2016

Study Completion

February 1, 2019

Last Updated

October 31, 2019

Record last verified: 2019-10

Locations

US(1)