MRI in Renal Tumors

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Device: Magnetic Resonance Imaging

• Registration Number: NCT02325921
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-25
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal tumor.	Magnetic Resonance Imaging	Patients \>18 years of age with histopathologically confirmed renal tumor diagnosis.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.	45 months

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands