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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287701
Enrollment
24
Registered
2014-11-11
Start date
2014-05-31
Completion date
2016-09-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

bladder cancer, MRI, PET

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.

Interventions

PROCEDUREPET/MRI

Simultaneous PET/MRI (3T system)

Sponsors

Society of Abdominal Radiology
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Tumor standardized uptake value (SUV) from 18-fluorodeoxyglucose PET/MRI scanwithin one week of study completionThe tumor SUV value obtained approximately one hour following 18-fluorodeoxyglucose administration will be measured.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026