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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
University Department of Radiology
RECRUITING
Cambridge
Contact Information
Primary
Ines Horvat-Menih, MD
ih357@cam.ac.uk
+44 1223 767062
Backup
Marta Wylot, PhD
mw699@medschl.cam.ac.uk
+44 1223 767062
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Other: 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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov