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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT02287701
Collaborator
Society of Abdominal Radiology (Other)
24
Enrollment
1
Location
1
Arm
28.1
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: PET/MRI
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
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 1, 2014
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: PET/MRI

Patient receives MRI

Procedure: PET/MRI
Simultaneous PET/MRI (3T system)
Other Names:
  • Siemens Biograph mMR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumor standardized uptake value (SUV) from 18-fluorodeoxyglucose PET/MRI scan [within one week of study completion]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone Medical Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • Society of Abdominal Radiology

    Investigators

    • Principal Investigator: Andrew Rosenkrantz, MD, NYU School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT02287701
    Other Study ID Numbers:
    • 14-00072
    First Posted:
    Nov 11, 2014
    Last Update Posted:
    Aug 14, 2017
    Last Verified:
    Aug 1, 2017
    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
    MRI
    PET
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Aug 14, 2017