A study looking at a new scan to improve the diagnosis of kidney cancer

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Open

Phase:

Other

This study is looking at whether using a new scan can help doctors tell if a kidney lump (tumour) is cancer or not. The scan is called a Sestamibi SPECT/CT (MIBI).

More about this trial

We know that around 3 out of 10 (around 30%) of kidney tumours are not cancer. These are called benign tumours.

At the moment, the only way to find out if a tumour 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 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 for this study think that a scan called Sestamibi SPECT/CT (MIBI) might be able to tell the difference between kidney tumours that are benign or cancer. If it can, it would mean people with a benign tumour might not need to have a biopsy or surgery to remove it.

MIBI scans use very small doses of radioactive Open a glossary item material.

This is a pilot feasibility Open a glossary item study. The researchers want to find out if it is possible to carry out similar research with a larger number of people in the future.

The main aim of this research is to find out if doctors can use MIBI scans instead of a biopsy for kidney tumours in the future. But first, they must do a smaller study to find out:

if people are willing to take part in different hospitals in the UK
if it is possible to do the main study
more about how MIBI scans work for people with kidney tumours

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 trial if all of the following apply. You:

have a solid lump (tumour) in your kidney that is more than 2cm but less than 7cm across and is only inside the kidney. Your doctors can see this on an MRI scan or CT scan . This is a clinical stage T1 tumour.
have not found out yet if the tumour is cancer or not
are going to have a sample of the area taken (biopsy) or you are going to have surgery to try and remove the tumour
are over 18 but not yet 95 years old

Who can’t take part

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

have other medical problems that could make taking part in the study difficult. Your doctor can tell you more.
are allergic to the radioactive substance (radiolabelled tracer) used for the MIBI scan. This is called 99mTc Sestamibi.
are female and are pregnant, breastfeeding or planning a pregnancy

Trial design

The study team would like 50 people from the UK to take part.

Everyone taking part has an MIBI scan before they have their biopsy or surgery. The study team would also like to look at the results of:

any blood tests you have
any scans you have
your biopsy or surgery
any further contact you have with your medical team (follow up)

Having the scan
Before you have the scan, someone from the team injects a small amount of radioactive substance (radiolabelled tracer) into a vein in your arm. Then, around 75 minutes later, you have a single photon emission computed tomography scan (SPECT) and a CT scan. The combined scan takes around 30 minutes. You lie still with your arms above your head for the scan.

Questionnaire
The study team ask you to complete a questionnaire the day after your scan appointment. It includes questions on:

your quality of life
your experience of your scan appointment

The questionnaire can be done by telephone, email or on an app.

Interview
The study team also ask if you would like to take part in an interview. It’s about how you feel about the scan being part of the diagnosis of kidney tumours. It takes around 10-20 minutes. You can take part even if you don’t decide to join the study. They record the interview. It can be:

face to face
over the phone
online

The team would be interested in your reasons if you decide not to take part in the study. This is so they can make the study better in the future.

Samples for research
The trial team would like to have access to tissue samples that were collected as part of your routine care at diagnosis (your biopsy or surgery). This is so they can look for biomarkers Open a glossary item .

The study team may also ask you if they can take an extra sample of tumour tissue at time of your biopsy. They might also like to take extra blood samples. These will be taken at the same time as any routine blood tests where possible.

The study team would like to use these extra tissue and blood samples for future research looking into:

biomarkers
more about how kidney tumours grow and develop

Hospital visits

You have one extra hospital visit if you take part in this study. This is so you can have your MIBI scan. The visit will take around 3-4 hours.

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.

Extra MIBI scan
The study team may ask if you would have another MIBI scan. You can say no to this and still take part in the main study.

Side effects

MIBI scans have been in routine use in the NHS to for other conditions including looking at the parathyroid glands Open a glossary item and heart muscle. There have been no reports of any serious problems after the scans.

The injection into the vein may cause pain and bruising, though this shouldn’t last long.

MIBI scans use ionising radiation. Ionising radiation can cause cell damage that may rarely, after many years or decades, turn into cancer.

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