“I had treatment last year and I want to give something back.”
A study looking at 3 different scans to monitor treatment in women with breast cancer that has spread to the bones (FABB study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a type of MRI scan and 2 types of PET-CT scan to see how well they pick up treatment related changes to areas of breast cancer spread to the bones.
More about this trial
To measure how well a cancer treatment is working, you usually have a combination of scans and blood tests. But although they work well in many situations, the scans doctors usually use do not show up changes to cancer in the bone very well.
Doctors in this study are looking at 3 types of scan that may give them clearer information about how cancer is responding to treatment. The first is a type of MRI scan called diffusion weighted MRI. This looks at movement of water molecules in cells, which shows up differently in cancerous and healthy tissue. The other 2 scans are types of PET-CT scans. These work by detecting levels of activity in cells, and may be able to pick up changes in cancer tissue due to treatment at an earlier stage than ordinary scans.
People taking part will have a set of these scans before and during treatment for cancer spread to their bones. The aim of this study is to use these scans to measure chemical activity in the cancer cells, and compare how well they pick up early treatment related changes in breast cancer spread to the bones. You will not have any direct benefit from taking part in this study. But in future, the results will be used to help people with cancer spread to the bones.
Who can enter
You may be able to enter this study if
- You are a woman with breast cancer that has spread, mainly to your bones
- Your breast cancer cells are sensitive to the hormone oestrogen (your cancer is
oestrogen receptor (ER) positive)
- You have either never had treatment before or you have had treatment but your cancer has continued to grow and you are starting hormone therapy alongside a drug to treat your bones such as a bisphosphonate or denosumab
- You are at least 18 years old
You cannot enter this study if you
- Are likely to need radiotherapy for pain in the next 8 weeks – you can ask your doctor about this
- Are likely to need injections of a drug called G-CSF to boost your white blood cell levels
- Cannot have an MRI scan for any reason, such as feeling very uncomfortable in small spaces, or having metal or a
pacemakerin your body
- Have poorly controlled diabetes, or any other medical condition that is uncontrolled
- Are pregnant or breastfeeding
This study will recruit 34 women. Everyone taking part will have 3 extra scans before they start the treatment already planned for them. These will be
- An MRI scan
- An FDG PET-CT scan
- A Fluoride PET-CT scan
You repeat these scans 8 weeks later. The team may ask you to have another fluoride PET-CT scan at 12 weeks. This is to confirm any changes they saw on the scans at 8 weeks. Each scan will be from the top of your head to your thighs.
The MRI scan will take about 20 minutes.
On the days of your FDG PET-CT scan you must not eat anything and only drink clear fluids for 4 hours before the scan. And, avoid hard exercise on the day of the scan. When you come for the scan you have a small amount of a radioactive tracer as an injection into a vein, through a small plastic tube called a cannula. You lie down in a quiet room for an hour to let the tracer travel round your body. You then have the scan, which will take between 30 and 40 minutes.
On the day of your fluoride PET-CT scan, you can eat and drink beforehand as normal. You have an injection and lie down in the same way as for the other scan. You also give a small blood sample before and after this scan.
At 3 of your routine clinic appointments you will have a blood test and fill out a questionnaire asking about any pain you are having.
You cannot have both types of PET-CT scan on the same day, but you can have one on the same day as the MRI scan. If you prefer, the team will try to arrange for your scans to be when you are already at the hospital for a routine appointment.
You fill out a questionnaire and have a blood test at about
- 8 weeks
- 3 months
- 6 months
You should not have any side effects from these study scans.
You will be exposed to a small amount of extra radiation by having the study PET-CT scans. We are all exposed to a very small amount of radiation during the course of a normal day (background radiation). The amount of radiation you would have from these scans is the same as about 35 years of background radiation.
After the PET-CT scans you should not have close contact with pregnant women, babies and young children for a few hours.
How to join a clinical trial
Professor Gary Cook
Breast Cancer Campaign
Guy's and St Thomas' NHS Foundation Trust
King's College London
NIHR Clinical Research Network: Cancer
Royal College of Radiologists