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Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques (IBM-Renal)

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ClinicalTrials.gov Identifier: NCT06016075
Recruitment Status : Recruiting
First Posted : August 29, 2023
Last Update Posted : October 25, 2023
Sponsor:
Information provided by (Responsible Party):
Ines Horvat-Menih, University of Cambridge

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Device: Hyperpolarised MRI Device: Sodium MRI Device: Deuterium metabolic imaging (DMI) MRI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Hyperpolarised MRI
Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
 Device: Hyperpolarised MRI
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.
 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.
Deuterium metabolic imaging (DMI) MRI
Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. LAC/PYR ratio [ Time Frame: 1 year ]
    LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.

  2. Total Sodium Concentration [ Time Frame: 1 year ]
    Total Sodium Concentration - in renal tumours

  3. Technical development of DMI in the abdomen [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016075


Contacts
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Contact: Ines Horvat-Menih, MD +44 1223 767062 ih357@cam.ac.uk
Contact: Marta Wylot, PhD +44 1223 767062 mw699@medschl.cam.ac.uk

Locations
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United Kingdom
University Department of Radiology Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Ines Horvat-Menih, MD    +44 1223 767062    ih357@cam.ac.uk   
Sponsors and Collaborators
University of Cambridge
Investigators
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Principal Investigator: Ferdia A Gallagher, MD PhD Principal Investigator
More Information
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Responsible Party: Ines Horvat-Menih, Doctor, University of Cambridge
ClinicalTrials.gov Identifier: NCT06016075    
Other Study ID Numbers: Radiology, Uni of Cambridge
22/EE/0136 ( Registry Identifier: Health Research Authority, East of England - Cambridge East Research Ethics Committee )
314155 ( Registry Identifier: Integrated Research Application System )
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: October 25, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases