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

NCT ID: NCT06016075

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-01-01

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hyperpolarised MRI

Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.

Group Type: OTHER

Hyperpolarised MRI

Intervention Type: DEVICE

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.

Group Type: OTHER

Sodium MRI

Intervention Type: DEVICE

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.

Group Type: OTHER

Deuterium metabolic imaging (DMI) MRI

Intervention Type: DEVICE

Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.

Interventions

Hyperpolarised MRI

Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Deuterium metabolic imaging (DMI) MRI

Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Ines Horvat-Menih

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ferdia A Gallagher, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

University Department of Radiology

Cambridge, Cambridgeshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Ines Horvat-Menih, MD

Role: CONTACT

Phone: +44 1223 767062

Email: ih357@cam.ac.uk

Marta Wylot, PhD

Role: CONTACT

Phone: +44 1223 767062

Email: mw699@medschl.cam.ac.uk

Facility Contacts

Ines Horvat-Menih, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 39461869 (View on PubMed)

Other Identifiers

22/EE/0136

Identifier Type: REGISTRY

Identifier Source: secondary_id

314155

Identifier Type: REGISTRY

Identifier Source: secondary_id

Radiology, Uni of Cambridge

Identifier Type: -

Identifier Source: org_study_id