Clinical trial NCT06016075: Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
Official title: Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Cancer
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 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

Primary outcomes:
measure: LAC/PYR ratio
timeFrame: 1 year
measure: Total Sodium Concentration
timeFrame: 1 year
measure: Technical development of DMI in the abdomen
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University Department of Radiology
state: Cambridgeshire
Study officials:
affiliation: Principal Investigator
name: Ferdia A Gallagher, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: