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Renal Tumour Imaging Using MRI

Not Applicable
Active, not recruiting
Conditions
Renal Cancer
MRI
Small Renal Mass
Kidney Cancers
Registration Number
NCT07173140
Lead Sponsor
University College, London
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Repeatability of proton density fat fraction (PDFF) measurements.1 year

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.

Diagnostic accuracy of proton density fat fraction (PDFF) to differentiate different histological subtypes of renal tumours.1 year

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University College London

🇬🇧

London, United Kingdom

University College London
🇬🇧London, United Kingdom

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