Clinical Trial

Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques

Study acronym: IBM-Renal
Recruiting
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Record status
This record was last updated December 5, 2024 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of 13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or 3) acquire imaging data from human tissues following the oral consumable of deuterated glucose. Data acquired during this physiological study will be used to optimise future imaging protocols.In the UK and possibly in other countries, there are some patients with renal masses that are over treated or undergo unnecessary procedures such as surgery or biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but after the procedure it is found that the mass was benign. The aim of this study is to determine whether one or all of these imaging techniques can differentiate between benign and malignant renal masses with the view to developing the techniques further and hopefully reducing the need for over treatment or unnecessary procedures in patients with benign masses.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-23; most recent amendment 2024-12-03.
Trial Details
NCT Number NCT06016075
Lead Sponsor University of Cambridge
Conditions Kidney Cancer
Enrollment 30 participants
Start Date 2023-01-01
Primary Completion 2025-08-31 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-05