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

NCT ID: NCT02287701

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-09-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET/MRI

Patient receives MRI

Group Type: EXPERIMENTAL

PET/MRI

Intervention Type: PROCEDURE

Simultaneous PET/MRI (3T system)

Interventions

PET/MRI

Simultaneous PET/MRI (3T system)

Intervention Type: PROCEDURE

Other Intervention Names

Siemens Biograph mMR

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society of Abdominal Radiology

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Rosenkrantz, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

14-00072

Identifier Type: -

Identifier Source: org_study_id