NCT02606513

Brief Summary

Tumors of the UUT are rare and usually presenting as micro- or macrohematuria either symptomatic or asymptomatic. Rapid advances in CT technology accelerated the research into the application of this new technology in the evaluation of the UUT and readily proved to be superior to other imaging modalities. Nevertheless the increase in radiation dose is a major issue of concern. Initial research into the utility of MRI in the evaluation of the UUT was promising, yet the success of CT together with the cost, limited availability and the longer duration of MR urography (MRU) examination, nearly halted the investigations into the feasibility of MRU which is unfortunate as MRU is a safe alternative to CT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

November 12, 2015

Last Update Submit

March 13, 2016

Conditions

Keywords

Computed Tomography UrographyMagnetic Resonance Urography

Outcome Measures

Primary Outcomes (1)

  • Percentage opacification score of different UUT segments using a comprehensive 3T MRU protocol in comparison with 3-phase CTU protocol.

    The UUT will be devided into 6 regions: Upper calyces, lower calyces, pelvis, and upper, middle and lower ureter, and the percentage opacification of each segment will be scored visually using 6 percentage-categories. Results of the opacification scores will be compared between MRU and CTU.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Performance of MRU in comparison to CTU

    through study completion, an average of 1 year

Study Arms (1)

Comparison of CTU vs MRU

EXPERIMENTAL

CTU is the primary test of choice for the evaluation of the UUT. The performance of MRU will be compared to that of CTU in the same patient population

Other: MR Urography; CT Urography

Interventions

Comparison of CTU vs MRU

Eligibility Criteria

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

You may qualify if:

  • All patients scheduled for CTU to rule out malignancy

You may not qualify if:

  • GFR \>45; BEnign conditions; Contrast allergy; Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital, Department of Clinical Radiology

Kuopio, 70029, Finland

Location

Related Publications (1)

  • Sudah M, Masarwah A, Kainulainen S, Pitkanen M, Matikka H, Dabravolskaite V, Aaltomaa S, Vanninen R. Comprehensive MR Urography Protocol: Equally Good Diagnostic Performance and Enhanced Visibility of the Upper Urinary Tract Compared to Triple-Phase CT Urography. PLoS One. 2016 Jul 6;11(7):e0158673. doi: 10.1371/journal.pone.0158673. eCollection 2016.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ritva Vanninen, MD; PhD

    Kuopio University Hospital; University of Eastern Finland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Radiology Consultant

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 17, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations