Advanced MRI in Renal Tumors.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Discriminating malignant from benign renal lesions using Apparent Diffusion Coefficient (ADC, a metric obtained by diffusion weighted MRI) value distribution analysis.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
- Additional value of tumor volume and patient characteristics to discriminate malignant from benign renal lesions.(45 months)