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Trial record 59 of 2243 for:    Recruiting, Not yet recruiting, Available Studies | Renal

MRI in Renal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02325921
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Radboud University

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 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.

Condition or disease Intervention/treatment
Renal Cell Carcinoma Device: Magnetic Resonance Imaging

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Advanced MRI in Renal Tumors.
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
(Partial) nephrectomy
Patients >18 years of age scheduled for undergoing (partial) tumor nephrectomy.
Device: 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 Outcome Measures :
  1. Discriminating malignant from benign lesions using Apparent Diffusion Coefficient (ADC) values, a metric obtained by diffusion weighted MRI. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients >18 years of age scheduled for undergoing (partial) tumor nephrectomy.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02325921

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Contact: Tim J. van Oostenbrugge, MD 0031243619097
Contact: Jurgen J Futterer, MD, PhD 0031243619097

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Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Tim J van Oostenbrugge, MD    0031 24 36 19097   
Contact: Jurgen J Futterer, MD, PhD    0031 24 36 19097   
Sponsors and Collaborators
Radboud University
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Principal Investigator: Jurgen J. Futterer, MD, PhD Radboud University

Additional Information:

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Responsible Party: Radboud University Identifier: NCT02325921     History of Changes
Other Study ID Numbers: NL49616.091.14
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: January 2018
Keywords provided by Radboud University:
Magnetic Resonance Imaging
Diffusion Weighted MRI
Diffusion Tensor Imaging
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases