MRI in Renal Tumors

February 20, 2020 updated by: Radboud University Medical Center

Advanced MRI in Renal Tumors.

Diagnostic imaging for renal masses of unknown nature using conventional imaging modalities such as 3 phase contrast-enhanced computed tomography (CT) is not always conclusive. After (partial) nephrectomy, 10-20 % of the resected tumors show benign histology which could not be identified on diagnostic imaging. With improved imaging techniques available, leading to improvements in characterisation of renal tumors, the number of unnecessary resections may be reduced. The objective of this study is to assess the ability to discriminate oncocytoma from RCC based on the ADC distribution parameters with addition of, tumor volume, and patient demographic characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500HB
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients >18 years of with a histopathologically confirmed renal tumor diagnosis.

Description

Inclusion Criteria:

  • Radiologic diagnosis of renal tumor based on previous ultrasonography, CT or MRI examinations.
  • Signed Institutional Review Board (IRB) approved informed consent form.
  • Being at least 18 years of age.
  • Histopathologically confirmed renal tumor diagnosis.

Exclusion Criteria:

  • Relative contra indications for MRI (metal device/foreign bodies, claustrophobia);
  • Active renal or perirenal infection;
  • Minor and/or incapacitated adult.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Renal tumor.
Patients >18 years of age with histopathologically confirmed renal tumor diagnosis.
Device: Magnetic Resonance Imaging
One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences, but without contrast enhancement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Discriminating malignant from benign renal lesions using Apparent Diffusion Coefficient (ADC, a metric obtained by diffusion weighted MRI) value distribution analysis.
Time Frame: 45 months
45 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.
Time Frame: 45 months
45 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Jurgen J. Futterer, MD, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49616.091.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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