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Clinical Trials/NCT02325921
NCT02325921CompletedNot Applicable

Advanced MRI in Renal Tumors.

Radboud University Medical Center1 site in 1 country39 target enrollmentStarted: October 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
1
Primary Endpoint
Discriminating malignant from benign renal lesions using Apparent Diffusion Coefficient (ADC, a metric obtained by diffusion weighted MRI) value distribution analysis.

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.(45 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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