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

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Procedure: PET/MRI

• Registration Number: NCT02287701
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/MRI	PET/MRI	Patient receives MRI

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States