A Two Site Pilot Study of Functional and Microstructural Imaging Using Magnetic Resonance Imaging in Patients With Renal Tumours
| Registry | NCT07173140, acronym RIM |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 30 (Actual) |
| Sponsor | University College, London (Other); collaborators: Royal Free Hospital NHS Foundation Trust, University College London Hospitals |
| Conditions | Renal Cancer, MRI, Small Renal Mass, Kidney Cancers |
| Interventions | MRI (Diagnostic test) |
| Dates | start 2024-11-20, primary completion 2025-06-19, completion 2025-09-30 (estimated), first posted 2025-09-15, last updated 2025-09-15 |
| Locations | 1 site in United Kingdom |
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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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Histological characterisation of renal tumours | No intervention | Histological samples of ten patients with tumour histology will be retreived from the Royal Free Hospital Biobank. Slides will be stained using H\&E and CD34 and cell size, stromal space and vascularity will be estimated and used to inform diffusion weighted imaging models. | |
| Comparison of microstructural MRI to histology | Experimental | Diagnostic Test: MRI | 10 patients with small renal tumours will undergo microstructural MRI. Following MRI the tumours will be surgically resected. The MRI will be co-registered with histology. The degree of correlation between the MRI and underlying histology will be determined. |
| Repeatability of MRI of small renal masses | Experimental | Diagnostic Test: MRI | The repeatability of the MRI scan of the small renal mass will be determined by participants undergoing a repeat MRI examination shortly after the first (within 14 d) on the same scanner. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| University College London | London | United Kingdom |