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NCT Number: NCT06016075

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

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.

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Department of Radiology

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location status: Recruiting

Location contact

Ines Horvat-Menih, MD

CONTACT

[email protected]

+44 1223 767062

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperpolarised MRI

Device

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

Sodium MRI

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

Device

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

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ines Horvat-Menih, MD

CONTACT

[email protected]

+44 1223 767062

Marta Wylot, PhD

CONTACT

[email protected]

+44 1223 767062

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Registry information

Acronym: IBM-Renal

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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