A study to measure how stiff tissue is around breast cancer to help plan treatment

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 1/2

This study measures how stiff tissue is around breast cancer and to see whether this can help doctors plan treatment better.

More about this trial

Doctors can use a scan called Magnetic Resonance Imaging (MRI) to see where your cancer is in the breast.

How stiff the tissue is around the cancer might affect how well the chemotherapy gets to the cancer. By finding out how stiff the tissue is doctors can make better decisions about the treatment you need.

Researchers think a new way of doing an MRI scan can help.

The new way is Magnetic Resonance Force (MRF). It is similar to having an MRI scan. You lie on the scanner bed on your stomach.

You place your arms on a movable padded table next to your body. Your breasts go into abreast coil. In the coil are specially designed paddles that hold your breasts in place.

The coil works with the MRI scanner to create images of your breasts. The paddles vibrate against your skin. This causes waves through your breast. It feels like the hum of a shaver and is harmless. These waves are then picked up by the MRI scanner and show up on the image of the scan.

To find out how useful MRF is researchers need to do a large clinical trial. Open a glossary item But before doing this they need to know if it is possible to do. This is a feasibility study.

In this feasibility study the team are looking for:

healthy volunteers
women with newly diagnosed breast who are having surgery
women with newly diagnosed breast cancer who are having chemotherapy before surgery

The aims of this feasibility study are to find out:

what the MRF image looks like for healthy women and for women who have breast cancer
if MRF shows whether there is cancer spread to the lymph nodes
if it can show how well chemotherapy is working

Who can enter

The following bullet points list 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 are a woman who is having treatment at St Guy’s and St Thomas’ Hospital and you:

have a newly diagnosed breast cancer that has grown into the surrounding tissue (invasive breast cancer)
are at least 18 years old

And one of the following apply.

Your cancer is at least 5mm across as seen on an ultrasound scan and you are having surgery to remove the cancer (lumpectomy) or the whole breast (mastectomy).

You are having chemotherapy before surgery to shrink the cancer (neoadjuvant chemotherapy).

As a healthy volunteer you may be able to join this study if you are at least 40 years old and haven’t had breast cancer.

Who can’t take part

You cannot join this study if any of these apply. You:

have had previous radiotherapy to your breast
can’t have an MRI scan for any reason, for example you have metal implants such as a pacemaker, surgical clips, pins or plates or cochlear implants (for deafness), you have a fear of being in closed spaces (claustrophobia) or you have small pieces of metal in your eyes
are known to be sensitive to the injection given during an MRI scan (known as contrast medium ). This applies only to women who have breast cancer
are having chemotherapy and are taking part in another clinical trial

Trial design

This is a phase 1/2 study. Everyone has the MRI-MRF scan.

Women with breast cancer have an injection of dye (contrast medium) into a vein before your scan.

Phase 1
For the phase 1 part the team need 50 healthy women to volunteer.

You have 1 MRI-MRF scan if you have gone through the menopause (post menopausal).

For women who haven’t gone through the menopause (pre menopausal) you have 2 scans. You have a scan:

at the beginning of your menstrual cycle (between days 7 and 15)
near the end of your menstrual cycle (between days 21 and 28)

The scan takes 30 minutes.

Phase 2
In this phase there are 2 groups of women.

For the 1st group the team need 100 women who are having surgery to remove the cancer (lumpectomy) or the whole breast (mastectomy). You have an MRI-MRF scan once before your surgery.

For the 2nd group the team need 175 women who are having chemotherapy to shrink their cancer before surgery (neoadjuvant chemotherapy). You have 5 MRI-MRF scans. You have a scan:

before starting chemotherapy
after the 1st cycle of chemotherapy
half way through your course of treatment with chemotherapy
when you change to having another type of chemotherapy drug
just before you have surgery

Blood and tissue samples
The team will ask women with breast cancer for some blood samples and tissue samples They use these samples to further their understanding of breast cancer and the MRI scan using MRF.

They take the blood sample when you’re having a blood tests for other reasons. And they take the tissue samples from when you’re having your operation to remove the cancer.

You don’t have to agree to these samples if you don’t want to. You can still take part in the study.

Hospital visits

You see the doctor before taking part to talk about the study and for a physical examination. The number of visits for MRF scans varies depending on the group you are in.

For women having surgery first you have an MRI-MRF scan before surgery.

For women having chemotherapy before surgery you have an MRI-MRF scan before each treatment cycle of chemotherapy.

Where possible the study team will arrange for the scans when you come to the hospital for a routine appointment.

For healthy volunteers who are pre menopausal you have 2 MRI-MRF scans. For those who are post menopausal you have 1 MRI-MRF scan.

You have the MRI-MRF scans at Guy’s Hospital. The study team will try to arrange the study visits to coincide with one of your normal (breast cancer) care appointments, where possible.

Side effects

An MRI is very safe and doesn’t use radiation. Some people can’t have an MRI but the checklist picks this up beforehand.

A member of the study team and or the radiographer monitor you during the MRI-MRF scan.

Some people are allergic to the dye, so your radiographer will check first about any medical conditions or allergies you have.
After the dye injection you may: