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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring bladder cancer, MRI, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/MRI

Arm Description

Patient receives MRI

Outcomes

Primary Outcome Measures

Tumor standardized uptake value (SUV) from 18-fluorodeoxyglucose PET/MRI scan
The tumor SUV value obtained approximately one hour following 18-fluorodeoxyglucose administration will be measured.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
August 10, 2017
Sponsor
NYU Langone Health
Collaborators
Society of Abdominal Radiology
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1. Study Identification

Unique Protocol Identification Number
NCT02287701
Brief Title
Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization
Official Title
Exploratory Investigation of Advanced PET/MRI Metrics for Bladder Cancer Characterization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Society of Abdominal Radiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
bladder cancer, MRI, PET

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/MRI
Arm Type
Experimental
Arm Description
Patient receives MRI
Intervention Type
Procedure
Intervention Name(s)
PET/MRI
Other Intervention Name(s)
Siemens Biograph mMR
Intervention Description
Simultaneous PET/MRI (3T system)
Primary Outcome Measure Information:
Title
Tumor standardized uptake value (SUV) from 18-fluorodeoxyglucose PET/MRI scan
Description
The tumor SUV value obtained approximately one hour following 18-fluorodeoxyglucose administration will be measured.
Time Frame
within one week of study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Rosenkrantz, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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