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

NCT06016075 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-05

No results posted yet for this study

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

Interventions

DEVICE

Hyperpolarised MRI

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

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Ferdia A Gallagher, MD PhD · Principal Investigator

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-08-31
Completion
2026-01-01

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06016075 on ClinicalTrials.gov