MRI in Renal Tumors

NCT ID: NCT02325921

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal tumor.

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

Magnetic Resonance Imaging

Intervention Type DEVICE

One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences, but without contrast enhancement.

Interventions

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Magnetic Resonance Imaging

One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences, but without contrast enhancement.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jurgen J. Futterer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Medical Center

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL49616.091.14

Identifier Type: -

Identifier Source: org_study_id

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