Renal Tumour Imaging Using MRI

N/AActive Not RecruitingNCT07173140

University College, London30 enrolled

Overview

This study investigates whether new types of MRI scans can tell the difference between different kidney tumours before surgery. Currently, imaging scans can detect kidney tumours and their size, but they aren't effective at determining the tumour type or its aggressiveness. Biopsies are an option, but they are invasive and may miss important cancerous cells. The aim is to use imaging to determine which tumours are aggressive so they can be treated early while avoiding unnecessary treatment of benign tumours. Patients with small renal tumours (≤ 7 cm) who meet the other inclusion and exclusion criteria will be asked to have an additional MRI scan at University College London Hospital prior to surgery. The imaging findings will be compared to the histology result from the removed tumour. In 10 patients the histology will be targeted to a specific location in the tumour based on the imaging. 10 patients will undergo a repeat MRI \<14 d apart to test whether the MRI scans can give the same answer twice (the test repeatability). The study is expected to run for 24 months and is funded by NIHR. The chief investigator for the study is Dr Richard Hesketh (rhesketh@ucl.ac.uk).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Renal Cancer MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 and over 2. Confirmed renal tumour ≤ 7 cm planned for surgical resection 3. Willing and able to provide written informed consent 4. Able to lie supine for the duration of an MRI Exclusion Criteria: 1. Contraindication to MRI e.g., cardiac pacemaker 2. Contraindication to MR contrast agents 3. Pregnancy 4. Breastfeeding 5. Deranged renal function (eGFR \<30) in the last three months. 6. Previous treatment of the renal tumour e.g., ablation, radiotherapy

Outcomes

Primary Outcomes

Diagnostic accuracy of proton density fat fraction (PDFF) to differentiate different histological subtypes of renal tumours.

PDFF mean values will be calculated for each tumour in arms 2 and 3. Following surgery the means for each histological subtype will be calculated and tested for statistical significance.

Time frame: 1 year

Repeatability of proton density fat fraction (PDFF) measurements.

Participants in arm 3 will undergo repeat scanning with a short time interval between scans. The repeatability of PDFF measurements will be assessed using within subject standard deviation, repeatability coefficients and Bland-Altman analysis.