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

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

NCT ID: NCT06016075

Condition: Kidney Cancer

Conditions: Official terms:
Kidney Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Hyperpolarised MRI
Description: Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Arm group label: Hyperpolarised MRI

Intervention type: Device
Intervention name: Sodium MRI
Description: 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.
Arm group label: Sodium MRI

Intervention type: Device
Intervention name: Deuterium metabolic imaging (DMI) MRI
Description: Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
Arm group label: Deuterium metabolic imaging (DMI) MRI

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Department of Radiology

Address:
City: Cambridge
Zip: CB2 0QQ
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Ines Horvat-Menih, MD

Phone: +44 1223 767062
Email: ih357@cam.ac.uk

Start date: January 1, 2023

Completion date: January 1, 2026

Lead sponsor:
Agency: University of Cambridge
Agency class: Other

Source: University of Cambridge

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06016075