This trial is active, not recruiting.

Condition renal cell carcinoma
Treatment magnetic resonance imaging
Sponsor Radboud University
Start date October 2014
End date December 2015
Trial size 48 participants
Trial identifier NCT02325921, NL49616.091.14


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 evaluate the diagnostic performance of diffusion weighted magnetic resonance imaging (DW-MRl) in assessing the nature of renal masses, including the use of diffusion tensor imaging (DTI).Therefore patients >18 years of age scheduled for undergoing (partial) tumor nephrectomy will undergo one additional MRI examination.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients >18 years of age scheduled for undergoing (partial) tumor nephrectomy.
magnetic resonance imaging
One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences (including diffusion tensor imaging), but without contrast enhancement.

Primary Outcomes

Discriminating malignant from benign lesions using Apparent Diffusion Coefficient (ADC) values, a metric obtained by diffusion weighted MRI.
time frame: 12 months

Secondary Outcomes

To distinguish histological subtypes of renal tumors using Apparent Diffusion Coefficient (ADC), mean diffusivity and Fractional Anisotropy (FA) values, metrics obtained by Diffusion Tensor Imaging (DTI).
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Planned to undergo (partial) tumor nephrectomy of at least one untreated tumor of one kidney; - Signed Institutional Review Board (IRB) approved informed consent form. Exclusion Criteria: - Relative contra indications for MRI (metal device/foreign bodies, claustrophobia); - Active renal or perirenal infection; - Minor and/or incapacitated adult.

Additional Information

Official title Advanced MRI in Renal Tumors.
Principal investigator Jurgen J. Futterer, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Radboud University.