Kidney Cancers, MRI, Renal Cancer, Small Renal Mass
Conditions
Keywords
Renal cancer, MRI, Small Renal Mass, Kidney Cancer
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).
Interventions
DIAGNOSTIC_TESTMRI
Participants undergo an additional MRI scan using novel MRI sequences
Sponsors
Royal Free Hospital NHS Foundation Trust
University College London Hospitals
University College, London
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Scan readers are blinded to lesion histology at the time of region of interest (ROI) drawing
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United Kingdom
Outcome results
None listed