MR Urography vs CT Urography
Opacification of the Upper Urinary Tract With MR Urography Compared to CT Urography
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
November 12, 2015
CompletedFirst Posted
Study publicly available on registry
November 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 15, 2016
March 1, 2016
1.9 years
November 12, 2015
March 13, 2016
Conditions
Keywords
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
EXPERIMENTALCTU 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
Interventions
Eligibility Criteria
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
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.
PMID: 27384417DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Ritva Vanninen, MD; PhD
Kuopio University Hospital; University of Eastern Finland
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