A study looking at 2 different scans to diagnose lung cancer (SPUTNIK)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Status:

Closed

Phase:

Phase 3

This study is comparing 2 different types of scan to diagnose lung cancer.

More about this trial

A small number of people are diagnosed with lung cancer at an early stage when there is a small single area of cancer in the lung (a nodule). People diagnosed at this stage may be able to have surgery to remove their cancer and have a very good chance of complete recovery.

Sometimes a single nodule in the lung is not cancer. An X-ray or CT scan can show a lung nodule. But a single test can’t tell doctors if the nodule is cancer or not. A PET scan may give doctors more information to help them work out whether a lung nodule is cancerous. But you may need to have a number of CT scans over a period of up to 2 years to establish that it is not cancerous. Your doctor may also take samples (biopsies).

In this study, researchers are looking at a different type of CT scan called a dynamic CT scan. You have this at the same time as the PET scan.

The dynamic CT scan provides different information to a PET scan. The aim of the study is to find which type of scan is better at diagnosing early stage lung cancer.

Who can enter

You may be able to enter this study if you

Have a single lung nodule shown on a CT scan that measures at least 8mm, but no more than 30mm across
Are at least 18 years old

You cannot enter this study if

You have had cancer in the last 2 years
Your doctors already know for sure whether or not your lung nodule is cancerous
You are not able to have either of the scans in the trial for any reason
You would not be able to have surgery or radiotherapy if you were diagnosed with early stage lung cancer
You are pregnant

Trial design

The study will recruit 375 people in the UK. Everybody taking part has both a dynamic CT scan and a PET scan. You would have a PET scan as part of your standard care whether or not you take part in the study.

If you agree to take part, you have both scans either on the same day, or within 3 weeks of each other.

When you have the dynamic CT scan, you have an injection of iodine into a vein. The scan then takes about 5 minutes.

You may have more CT scans 3 months, 9 months and 2 years later. You may also have biopsies. This is part of standard care, but the study team will record the results of any scans and biopsies you have. The study team will ask if they can look at your medical records during the next 2 years.

They will also ask you to take part in a sub study to help them identify symptoms of lung disease. You don’t have to join this study if you don’t want to, you can still take part in the main study.

If you agree to join the sub study, you fill out a questionnaire about your health and any symptoms you have. It takes about 30 minutes. You can leave the completed questionnaire at the clinic or post it back in a pre-paid envelope.

Hospital visits

You may have an extra hospital visit if you have the dynamic CT scan on a different day to your PET scan.

Side effects

The iodine injection you have before the dynamic CT scan is commonly used and generally safe. Occasionally there are side effects such as itching, rash, feeling or being sick, diarrhoea, headache, dizziness and high temperature (fever).

Recruitment start:

07/01/2013

Recruitment end:

20/12/2016

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.

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Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Fiona Gilbert

Supported by

NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University Hospital Southampton NHS Foundation Trust
University of Southampton

Freephone 0808 800 4040

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