Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06016075

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

Led by University of Cambridge · Updated on 2024-12-05

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Department of Radiology

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Actively Recruiting

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Research Team

I

Ines Horvat-Menih, MD

CONTACT

M

Marta Wylot, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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