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

Sponsor: University of Cambridge

NCT ID: NCT06016075

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Hyperpolarised MRI (device), Sodium MRI (device), Deuterium metabolic imaging (DMI) MRI (device)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Hyperpolarised MRI — device: Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. · 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
30
Started
2023-01-01
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for kidney cancer
  • • NA - 30 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with kidney cancer

Where?

  • • Cambridge - University Department of Radiology

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Kidney Cancer

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Over 18 years old
  • ✓Able to and provide written agreement to take part 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 kidney masses, as determined by standard...

Who cannot take part

  • ✗safety concern 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...
  • ✗Clinically significant heart, lung or neurological diseases as determined by the investigators
  • ✗Laboratory abnormalities that may impact on the study results
See the full 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

Where Is This Study? (1 UK site)

University Department of Radiology

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Ines Horvat-Menih, MD+44 1223 767062ih357@cam.ac.uk

How to Get in Touch

Ines Horvat-Menih, MD

Sponsor contact

CONTACT

+44 1223 767062 ih357@cam.ac.uk

Marta Wylot, PhD

Sponsor contact

CONTACT

+44 1223 767062 mw699@medschl.cam.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-12