Renal Tumour Imaging Using MRI

NCT ID: NCT07173140

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2025-09-30

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).

Conditions

Renal Cancer; MRI; Small Renal Mass; Kidney Cancers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Histological characterisation of renal tumours

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comparison of microstructural MRI to histology

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.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DIAGNOSTIC_TEST

Participants undergo an additional MRI scan using novel MRI sequences

Repeatability of MRI of small renal masses

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.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DIAGNOSTIC_TEST

Participants undergo an additional MRI scan using novel MRI sequences

Interventions

MRI

Participants undergo an additional MRI scan using novel MRI sequences

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University College London Hospitals

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University College London

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

162190

Identifier Type: -

Identifier Source: org_study_id