NCT02287701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

October 15, 2014

Last Update Submit

August 10, 2017

Conditions

Bladder Cancer

Keywords

bladder cancerMRIPET

Outcome Measures

Primary Outcomes (1)

  • 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.

    within one week of study completion

Study Arms (1)

PET/MRI

EXPERIMENTAL

Patient receives MRI

Procedure: PET/MRI

Interventions

PET/MRIPROCEDURE

Simultaneous PET/MRI (3T system)

Also known as: Siemens Biograph mMR
PET/MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Andrew Rosenkrantz, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2014

First Posted

November 11, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

US(1)