A study looking at 3 new types of MRI scan to diagnose kidney cancer (IBM Renal)
Cancer type:
Status:
Phase:
This study is looking at whether using new types of MRI scan can help doctors tell if a kidney lump (tumour) is cancer or not. The researchers are looking at:
- deuterated metabolic imaging (DMI) MRI
- hyperpolarised MRI
- sodium MRI
This study is being done at Addenbrooke’s Hospital in Cambridge. You can’t volunteer to join the study. You can only take part if you are having care at Addenbrookes. Your healthcare team can check if you are suitable for the study and refer you.
Cancer Research UK supports this study.
More about this trial
The only way to find out if a 
in the kidney is cancer or not is by:
- taking out a sample of cells to look at under the microscope (
biopsy ) - removing the tumour along with part, or all, of the kidney (surgery)
This is how people are diagnosed with kidney cancer at the moment. Biopsies and surgery have risks as well as benefits. We also know from other studies that understanding if a tumour is cancer or not, makes a difference to people’s decision on whether to have surgery.
The researchers think that specialist MRI scans might be able to tell the difference between kidney tumours and cancerous tumours. They are doing this study to try and find out. If they can tell the difference, it would mean people with a benign tumour might not need to have a biopsy or surgery to remove it.
All 3 scans are similar to a standard MRI scan. But there are some differences.
Deuterated Metabolic Imaging (DMI) MRI
Deuterium helps the researchers see the kidney in more detail on the scan. They look at how the tumour uses a type of sugar called glucose. They want to see if cancerous kidney tumours use glucose differently to benign tumours.
Hyperpolarised MRI
The researchers look at how the tumour uses pyruvate on the MRI scan. Pyruvate is a substance which is found naturally in your body and is a breakdown product of glucose. We know from research that cancer tissue uses up pyruvate more quickly than benign tumours.
Sodium MRI
This MRI scan is looking at the amount of sodium in your body. We know that cancer tissue tends to have more sodium than normal tissue. So, the researchers think that they could use this scan to see how much sodium there is in a tumour. And to see if this could be used to work out if a tumour is cancer or not.
Everyone taking part
The study team compares what is happening in the kidney on your MRI scan to:
- your other kidney
- other people taking part in the study with a similar condition to you
- other people taking part in the study who have had the same scan
As part of your usual care, you have a biopsy or surgery to see if your tumour is cancer or not. When you get the results, the researchers compare this to the results seen from the MRI scan.
The main aims of this study are to:
- see if each type of scan can be used to work out if a kidney tumour is cancer or not
- look at two different types of scans from the same person. The researchers see if this gives them more information than just one scan.
- find out if there is a connection between
biomarkers from the tumour and what can be seen on the MRI scan
Who can enter
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
- have a solid lump (tumour) on your kidney which doctors think may, or may not, be cancer. Your doctors can see this on a
scan , or they have taken a tissue sample during a biopsy or surgery. - are willing to use a reliable contraceptive for at least two weeks before, and up to two weeks after each scan if there is a chance you could become pregnant. Or if you are male and your partner could become pregnant, you are willing to use reliable contraception up to 2 weeks after each scan. The study team can give you advice on suitable contraception.
- are able to go to the hospital for at least one study visit
- have satisfactory blood test results
- are aged 18 years or over
Who can’t take part
You cannot join this study if any of these apply. You:
- are not able to have an MRI scan. This could be because you have a
pacemaker , inner ear implant (cochlear implant) or metal plates for bone fractures. - are not able to tolerate having an MRI scan. Some people find that having an MRI scan feels claustrophobic, but the staff will do all they can to make you comfortable.
- are pregnant or breastfeeding
- have a type of copper intrauterine contraceptive device (IUCD) which means an MRI scan is not safe. Your doctor will know this.
- have a serious
heart problem , lung problem or brain and nervous system (neurological) disorder. Your doctor will know more. - have any other serious physical or mental health problem that would make it difficult for you to take part
Trial design
The researchers need around 30 people to take part in this .
At the beginning of the study, the researchers put you into one of 2 groups. This depends on whether they suspect your kidney tumour is cancer or not:
- people with a suspected
benign tumour - people with a suspected cancerous tumour
Everybody has one new type of MRI scan.
- 10 people have a deuterated metabolic imaging (DMI) MRI.
- 10 people have a hyperpolarised MRI.
- 10 people have a sodium MRI.
The researchers aim to have equal numbers of people with suspected benign and suspected cancerous tumours in each group. They think this will help them to test each scan properly. So, in each scan group:
- around 5 people have a tumour that doctors think is more likely to be cancer and
- around 5 people have a tumour that doctors think is more likely to be benign
Each scan takes around 75 to 90 minutes.
Deuterated Metabolic Imaging (DMI) MRI
You don’t have anything to eat or drink for 6 hours before your DMI MRI. This is so there is no extra sugar in your body that the scan might pick up. You can drink small amounts of water during this time.
You drink water with a sugar solution with deuterium added before your scan. Deuterium is not . You drink this around 75 minutes before the scan starts.
This scan is done in parts. You get off the scanner at certain times for the team to change equipment.
Hyperpolarised MRI
During the scan, the researchers inject hyperpolarised pyruvate using a fine tube that goes into your vein (cannula). Hyperpolarised pyruvate is not radioactive.
Sodium MRI
You don’t need any special preparation for this scan.
Repeat scan
The researchers may ask if you are willing to have a repeat scan. This is optional. You can say no and still take part in the main study.
You have the same scan within a week.
The researchers compare the first scan and repeat scan to see if they give the same results.
Second scan
The researchers may ask if you’re willing to have a second scan if you are not having a repeat scan. This is optional. You can say no and still take part in the main study.
This is a different study scan from the first. You have it within 2 weeks of your first scan.
The study team will let you know:
- which scan you will have
- any preparation you need to do before the scan
- how long the scan takes – second scans can take less time
The researchers want to look at the first and second scan together to see if they get more detailed information this way.
Tissue and blood samples for research
The researchers ask to take a sample of your tumour if you have surgery or a biopsy as part of your routine care.
You don’t have to give these samples if you don’t want to. You can still take part in the study.
The study team would like to compare the tissue samples with the results of the scans. The researchers use the samples to learn more about kidney cancer, including any that might be involved.
The researchers ask you to have blood tests for research each time you go to the hospital for a scan. These blood tests are optional. You can say no and still take part in the study. The researchers use the blood samples to look at the levels of blood cells and salts in the blood.
Follow up
The study team will ask your permission to contact your hospital or GP team for around a year after taking part.
This is to find out how you are getting on and if there have been any changes to your health.
Hospital visits
Everyone has at least one hospital visit. This is for the MRI scan.
You see the study team and have some tests before taking part. These include:
- a
physical examination - blood tests - if you have not had these in the last 2 weeks
- a pregnancy test if there is any chance you could become pregnant
You have these tests on the same day as your scan.
You might have a finger prick blood test to check your level if you are having a DMI or hyperpolarised scan.
You have a second hospital visit if you are having either a:
- repeat scan or
- second scan
The researchers take any tissue samples you have agreed to at your planned biopsy or surgery visit. This means that you don’t need an extra hospital visit to give tissue samples as part of the study.
You then have the usual care and follow up everyone with a kidney tumour has in the NHS. Your medical team will give you information on this.
Side effects
MRI scans are a safe procedure that are in routine use. They do not use x-rays or radioactivity.
DMI MRI
There are no expected side effects from having the deuterium glucose drink. Some people might have an allergic reaction, but this is unlikely.
Hyperpolarised MRI
You might have some mild and short lasting side effects from the pyruvate injection. These include:
- feeling hot
- having a metallic taste in your mouth
- dizziness
These are rare.
We have more information about:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Ferdia Gallagher
Supported by
Cancer Research UK
Cambridge University Hospitals NHS Foundation Trust
National Institute for Health Research (NIHR)
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
