Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
bladder cancer, MRI, PET
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: PET/MRI
Type: Device
Overall Status
Recruiting
Summary
The overarching goal of this project is to explore whether associations exist between metrics obtained from PET/MRI incorporating advanced MRI sequences and features of bladder cancer, including grade, stage, and treatment response.
Detailed Description
The investigators will assess an advanced non-Gaussian diffusion-weighted imaging (DWI) model termed diffusion kurtosis imaging, multi-echo T2 mapping, dynamic contrast-enhanced (DCE) MRI using a motion-robust high-temporal and high-resolution radial acquisition scheme employing compressed sensing, and simultaneously acquired 18-fluoro (18F)- fluorodeoxygluclose (FDG) data. Preliminary data demonstrates the investigators ability to execute and evaluate all of these techniques at the investigators center. The investigators hypothesize that these techniques will be sensitive to functional and metabolic differences between subsets of bladder cancer cases and will improve upon the performance of current imaging protocols in bladder cancer characterization. Moreover, the investigators believe that these techniques will provide complementary information, such that they may be combined in a synergistic fashion for bladder cancer evaluation.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologic or imaging evidence of urothelial carcinoma of the bladder

- Age ≥ 18 years of age

- If female of childbearing potential, pregnancy test is negative. (In these instances, the patient will need to provide documentation of negative pregnancy test results.)

Exclusion Criteria:

- Inability to tolerate MRI including conditions such as claustrophobia or inability to lay flat for > 45 minutes.

- Presence of pacemaker/implantable cardiac device (ICD) or perfusion pumps

- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants.

- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
Location
NYU Langone Medical Center
New York, New York, United States
Status: Recruiting
Contact: Simone Rainey - 212-263-2710 - simone.rainey@nyumc.org
Start Date
May 2014
Completion Date
May 2016
Sponsors
New York University School of Medicine
Source
New York University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page