MRI in Renal Tumors

NCT02325921 | Completed

• 1 other identifier: NL49616.091.14
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

Magnetic Resonance Imaging; Diffusion Weighted MRI; Diffusion Tensor Imaging

Outcome Measures

Primary Outcomes (1)

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

  45 months

Secondary Outcomes (1)

• Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.

  45 months

Study Arms (1)

Renal tumor.

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

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DEVICE

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

Renal tumor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jurgen J. Futterer, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 25, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

NL (1)