A study looking at improving the quality of images taken by an MRI scan (MISSION-Fumarate)
Cancer type:
Status:
Phase:
This study is looking at a imaging agent to improve the information doctors can get from 
.
It is open to people with cancer and healthy volunteers. The study is being done at Addenbrooke’s Hospital, Cambridge.
More about this trial
An MRI scan is one of the tests doctors use to diagnose cancer. As part of the scan, you might have a . This is called an imaging agent. Using an imaging agent like the contrast medium can improve the quality of the MRI scan and the information doctor's get from it. Researchers are looking at other imaging agents to gain further information from MRI scans.
In this study the researchers are looking at an imaging agent called hyperpolarised fumarate. Fumarate is a natural substance found in the body. It is also used as an additive in food and medicine.
Healthy tissue, cancer tissue and dying tissue in the body breaks down hyperpolarised fumarate differently. This is not seen on a standard MRI scan. So, by using hyperpolarised fumarate during the MRI scan doctors can see things that they can’t see on a standard MRI scan.
In this study the team are looking for healthy volunteers and people who have cancer.
The aims of the study are to find out:
- how safe it is to give hyperpolarised fumarate
- if they can use hyperpolarised fumarate to detect normal tissue and cancer tissue
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 satisfactory blood test results
- are at least 18 years old
- are willing to use reliable contraception for at least 2 weeks before the injection and 2 weeks after the injection if you or your partner could become pregnant
People who have cancer
Both of the following must also apply. You:
- have an area of cancer that can be measured on a scan
- are able to attend all of the study visits. The team will tell you how often and when the visits are.
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, you have bits of metal such as surgical clips in your body or you can’t tolerate being in small confined spaces.
- are pregnant or breastfeeding
- have certain
heart problems , certain lung problems or certain nerve problems. Your doctor will know about this. - have any other medical condition or mental health problem that could affect you taking part in the study
Healthy volunteers
You cannot join if you are taking regular medication, apart from the contraceptive pill, which could affect the study. A member of the team will ask what medicines you are taking and will know if this applies to you.
Trial design
Everyone will have hyperpolarised fumarate. You have it as an injection into a vein in the arm through a thin plastic tube (cannula).
Healthy volunteers
The team need up to 20 healthy volunteers to take part. Up to 9 people will have the fumarate injection and not have an MRI scan. Up to 11 people will have the fumarate injection and have an MRI scan.
The team will tell you which group you are in.
Those having the injection only
The first few people taking part will have a low dose of the fumarate injection. If they don’t have any serious side effects the next few people will have a higher dose. And so on, until they find the best dose.
After having the injection, a member of the study team will take blood samples and do tests such as blood pressure, heart rate, temperature and a heart trace (). This is to check the safety and possible side effects of hyperpolarised fumarate.
You have this at Addenbrooke’s Hospital. You will be in the hospital for at least 1 hour.
The team will give you a contact number to call if you have any questions or concerns when you are home.
Within 2 days after the injection a member of the team will phone you. This is to see how you are.
The team will ask if you are willing to come back another time to have the injection followed by an MRI scan. You don’t have to agree to this.
This visit will take up to 2 hours. You will spend maximum 60 minutes in the scanner.
The team will ask if you are willing to come back within 5 days for another injection and MRI scan. You don’t have to agree to come back for this.
People with cancer
The team need up to 70 people with cancer to take part.
There are some MRI scans you have to have as part of the study. There are others you don’t have to agree to have.
Before starting treatment, you have a baseline scan using the fumarate injection. The team will ask if you are willing to have another scan using the fumarate injection. This is within 5 days after the first scan. You don’t have to agree to the second scan.
During treatment, you have a scan with the injection. This is about a month after the initial scan before treatment. The team will also ask if you are willing to have another scan again using the injection. This is within 5 days after the other scan. You don’t have to agree to the second scan.
After treatment, the team will ask if you are willing to have another scan without the injection and then another scan using the injection within 5 days after. You don’t have to agree to have either of these scans.
Each visit can take up to 2 hours.
Cancer tissue samples for research
The team will ask your permission for tissue samples (), one before treatment and one after treatment.
Where possible they will ask for a piece of tissue from previous biopsies or from the tissue removed if you have or had surgery.
If this is not possible they will ask for 2 fresh biopsies. They will only take these if it is safe to do so.
You don’t have to agree to this.
Hospital visits
Everyone sees the doctor for tests before taking part. These tests include:
- a
physical examination - blood tests
- heart trace (ECG) if needed. Your doctor will tell you if you do.
The team may phone you up to 2 days after each MRI scan. This is to see how you are.
Side effects
The study team monitor you during the scans and afterwards.
This is the first time that fumarate is being used in people. It is a natural substance that occurs in the body. Government bodies have approved the use of fumarate as an additive in food and medicines. The team consider it is safe to use.
We have information about MRI scans
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
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
National Cancer Imaging Translational Accelerator (NCITA)
National Institute for Health and Care Research (NIHR)
The Mark Foundation for Cancer Research
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
