MRI in Renal Tumors

Renal Cell Carcinoma Clinical Trial

Official title:

Advanced MRI in Renal Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325921
• Other study ID #: NL49616.091.14
• Status: Completed
• Start date: October 2014
• Est. completion date: June 2018

Study information

• Verified date: February 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Device:
• Magnetic Resonance Imaging
One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences, but without contrast enhancement.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discriminating malignant from benign renal lesions using Apparent Diffusion Coefficient (ADC, a metric obtained by diffusion weighted MRI) value distribution analysis.		45 months
Secondary	Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.		45 months