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Completed

NCT Number: NCT07713654

Tumor Heterogeneity of Renal Tumors Assessed by Multiparametric MRI With Direct Radiological-histopathological Correlation: an Explorative Study

In this study, high-resolution magnetic resonance imaging scans (MRI/mpMRI) were performed before surgical removal of the tumor and then compared with microscopic examinations of the tumor. Instead of looking at just one single area, the study compared many small, spatially correlated sections of the tumor-almost like creating a mini-map of the entire tumor.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

A prospective single-center pilot study was performed on patients with solid renal tumors ≥2cm undergoing nephrectomy. Each patient underwent advanced preoperative 3.0T-mpMRI (including T2-weighted, pre-/postcontrast T1-weighted sequences, CS imaging, IVIM-DWI, and mapping). Tumor regions were jointly defined by a pathologist and radiologist. Identical Regions of Interest (ROIs) were assessed across all sequences to derive quantitative mpMRI parameters. Histopathology provided quantified regional fractions: viable tumor, fibrosis, hemorrhage, and cystic/necrotic components. Associations between these parameters were evaluated using Spearman's rank correlation and univariable linear regression at the regional level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with confirmed or suspected renal tumor with an approx. size of ≥ 2 cm who are scheduled for clinical MRI examination and surgical resection of the tumor
  • Informed consent as documented by signature (Informed Consent Form)
  • Patients ≥18 years of age

Exclusion criteria

  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study and lack of safe contraception
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).
  • Patients with known hypersensitivity reactions to MRI contrast agents will undergo the examination without application of a contrast agent

Treatment and study plan

mpMRI

Diagnostic Test

Multiparametric MRI prior to nephrectomy

Primary outcomes

  1. Viable tumor fraction

    Time frame: Baseline

    Fraction of tumor that is viable

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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