NCT06016075Recruiting
Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 23 Aug 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- University of Cambridge
- Diseases
- Kidney cancer
- NCT number
- NCT06016075
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jan 2023 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
- Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators
Lab values
- Laboratory abnormalities that may impact on the study results
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Department of Radiology Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.