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OpenTrials
Completed

NCT Number: NCT02287701

Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Medical Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/MRI

Procedure

Simultaneous PET/MRI (3T system)

Other names: Siemens Biograph mMR

Primary outcomes

  1. Tumor standardized uptake value (SUV) from 18-fluorodeoxyglucose PET/MRI scan

    Time frame: within one week of study completion

    The tumor SUV value obtained approximately one hour following 18-fluorodeoxyglucose administration will be measured.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Society of Abdominal Radiology

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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