Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques (IBM-Renal)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Cancer
• Intervention / Treatment: Device: Hyperpolarised MRI; Device: Sodium MRI; Device: Deuterium metabolic imaging (DMI) MRI

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ines Horvat-Menih, MD; Phone Number: +44 1223 767062; Email: ih357@cam.ac.uk
• Study Contact Backup: Name: Marta Wylot, PhD; Phone Number: +44 1223 767062; Email: mw699@medschl.cam.ac.uk

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • University Department of Radiology
      • Contact: Ines Horvat-Menih, MD; Phone Number: +44 1223 767062; Email: ih357@cam.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years old
• Able to and provide written informed consent to participate
• If female, postmenopausal or if women of child bearing potential (WOCBP) using a suitable contraception
• If male, using a suitable contraceptive method for the duration of the study
• Radiologically suspected or pathologically confirmed benign or malignant renal masses, as determined by standard clinical practice
• Capable of undergoing a minimum of one study visit

Exclusion Criteria:

• Contraindication or inability to tolerate MRI
• Pregnant or actively breast-feeding woman
• If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI safe at 3 T (researcher to confirm)
• Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
• Laboratory abnormalities that may impact on the study results
• Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hyperpolarised MRI; Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.	Device: Hyperpolarised MRI; Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Other: Sodium MRI; MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.	Device: Sodium MRI; MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.
Other: Deuterium metabolic imaging (DMI) MRI; Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.	Device: Deuterium metabolic imaging (DMI) MRI; Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sodium Concentration	Total Sodium Concentration - in renal tumours	1 year
LAC/PYR ratio	LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.	1 year
Technical development of DMI in the abdomen	Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.	1 year

Collaborators and Investigators

• Sponsor: University of Cambridge
• Investigators: Principal Investigator: Ferdia A Gallagher, MD PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms
• Other Study ID Numbers: Radiology, Uni of Cambridge; 22/EE/0136 (Registry Identifier: Health Research Authority, East of England - Cambridge East Research Ethics Committee); 314155 (Registry Identifier: Integrated Research Application System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No