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MRI in Renal Tumors

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ClinicalTrials.gov Identifier: NCT02325921
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : February 24, 2020
Sponsor:
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 assess the ability to discriminate oncocytoma from RCC based on the ADC distribution parameters with addition of, tumor volume, and patient demographic characteristics.

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Advanced MRI in Renal Tumors.
Actual Study Start Date : October 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018


Group/Cohort Intervention/treatment
Renal tumor.
Patients >18 years of age with histopathologically confirmed renal tumor diagnosis.
Device: Magnetic Resonance Imaging
One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences, but without contrast enhancement.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions. [ Time Frame: 45 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 with a histopathologically confirmed renal tumor diagnosis.
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02325921


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Jurgen J. Futterer, MD, PhD Radboud University
Additional Information:

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02325921    
Other Study ID Numbers: NL49616.091.14
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases