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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02287701
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : August 14, 2017
Society of Abdominal Radiology
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: PET/MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization
Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: PET/MRI
Patient receives MRI
Procedure: PET/MRI
Simultaneous PET/MRI (3T system)
Other Name: Siemens Biograph mMR

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02287701

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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Society of Abdominal Radiology
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Principal Investigator: Andrew Rosenkrantz, MD NYU School of Medicine

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Responsible Party: NYU Langone Health Identifier: NCT02287701     History of Changes
Other Study ID Numbers: 14-00072
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:
bladder cancer

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases