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

Kidney Cancer Clinical Trial

— IBM-Renal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016075
• Other study ID #: Radiology, Uni of Cambridge
• Secondary ID: 22/EE/0136314155
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: October 2023
• Source: University of Cambridge
• Contact: Ines Horvat-Menih, MD
• Phone: +44 1223 767062
• Email: ih357[@]cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms

Intervention

Device:
• Hyperpolarised MRI
Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
• 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.
• Deuterium metabolic imaging (DMI) MRI
Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.

Locations

Country	Name	City	State
United Kingdom	University Department of Radiology	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total Sodium Concentration	Total Sodium Concentration - in renal tumours	1 year
Primary	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