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| Name | Class |
|---|---|
| Royal Free Hospital NHS Foundation Trust | OTHER |
| University College London Hospitals | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | Participants undergo an additional MRI scan using novel MRI sequences |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41495369 | Derived | Sen S, Smith L, Caselton L, Clemente J, Tran M, Punwani S, Atkinson D, Hesketh RL, Panagiotaki E. Dual deep learning approach for non-invasive renal tumour subtyping with VERDICT-MRI. Npj Imaging. 2026 Jan 6;4(1):2. doi: 10.1038/s44303-025-00135-6. |
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Immediately
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2024 | Sep 8, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Scan readers are blinded to lesion histology at the time of region of interest (ROI) drawing
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |