Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
IBM-Renal
3 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedDecember 5, 2024
December 1, 2024
2.7 years
August 23, 2023
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Total Sodium Concentration
Total Sodium Concentration - in renal tumours
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
Study Arms (3)
Hyperpolarised MRI
OTHERHyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Sodium MRI
OTHERMRI 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
OTHERDrink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
Interventions
Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
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.
Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Department of Radiology
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Related Publications (1)
Horvat-Menih I, McLean MA, Zamora-Morales MJ, Wylot M, Kaggie J, Khan AS, Gill AB, Duarte J, Locke MJ, Mendichovszky I, Li H, Priest AN, Warren AY, Welsh SJ, Jones JO, Armitage JN, Mitchell TJ, Stewart GD, Gallagher FA. Multiarm, non-randomised, single-centre feasibility study-investigation of the differential biology between benign and malignant renal masses using advanced magnetic resonance imaging techniques (IBM-Renal): protocol. BMJ Open. 2024 Oct 26;14(10):e083980. doi: 10.1136/bmjopen-2024-083980.
PMID: 39461869DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ferdia A Gallagher, MD PhD
Principal Investigator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 23, 2023
First Posted
August 29, 2023
Study Start
January 1, 2023
Primary Completion
August 31, 2025
Study Completion
January 1, 2026
Last Updated
December 5, 2024
Record last verified: 2024-12