A study looking for a new way to work out oxygen levels in throat cancer (BoHEMIaN study)

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

Cancer type:

Head and neck cancers
Mouth (oral) cancer

Status:

Closed

Phase:

Other

This study is aiming to develop a simple method of working out which patients have a cancer of the part of the throat just behind the mouth (oropharynx) with a low level of oxygen, as these cancers can be more difficult to treat.

More about this trial

Doctors usually treat head and neck cancer that has spread to lymph nodes Open a glossary item in the neck with a combination of chemotherapy and radiotherapy (chemoradiation Open a glossary item). But although cancers often respond well to this, sadly some do not, and can continue to grow or come back again quickly. Doctors call these aggressive cancers. Researchers want to find ways to identify early on those who have more aggressive, harder to treat cancers so they can choose their treatment with this in mind, and in future, design new treatments.

We know that cancers with low levels of oxygen are harder to treat with radiotherapy. But doctors cannot tell in advance who will have cancer with low levels of oxygen. There is a scan that shows oxygen levels in a cancer, called a copper ATSM PET-CT scan. But this is time consuming, expensive and not available in many hospitals. So researchers in this study are looking at whether they can identify genes that predict low levels of oxygen in cancer cells. They could then perhaps develop a simpler test.

They will carry out a copper ATSM PET-CT scan and take blood samples from people with cancer of the oropharynx. And, study stored cancer samples from those taking part. They will look for any relationship between the samples and scan results, to see if any features (biomarkers) in the samples can be used to predict how the cancer will behave.

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with head and neck cancer in the future.

Who can enter

You may be able to enter this study if

  • You have a type of cancer of the oropharynx called a squamous cell carcinoma
  • Your cancer is stage 3 or 4
  • You are due to have a combination of chemotherapy and radiotherapy (chemoradiation) aimed at curing your cancer
  • You have satisfactory blood test results
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have given permission for your original cancer tissue sample (biopsy) to be stored in the Head and Neck Tissue and data bank at Guy’s and St Thomas’ NHS Foundation Trust
  • You are at least 18 years old

You cannot enter this study if you

  • Have an illness or condition that may mean you could not have the radiotracer injection, or may make you unwell if you took part - you can ask your doctor about this
  • Have had any other cancer apart from basal cell skin cancer
  • Open your bowels or pass urine before you can reach the toilet
  • Are pregnant or breastfeeding

Trial design

This study will recruit 40 people. Everyone taking part will have a PET-CT scan with an injection of copper ATSM tracer, about a week before they start radiotherapy.

When you come for the scan the team will put a small plastic tube called a cannula into a vein in your arm or hand, and take a sample of blood. You have the radioactive tracer as an injection into the vein. Then you rest for 45 to 60 minutes, to let the tracer reach your head and neck. You then have the scan, which takes about 15 minutes.

The team will also study the biopsy sample stored at the hospital, to look at in more detail and compare what they find with the results of this scan.

Hospital visits

You will make one extra hospital visit for your study scan.

Side effects

You will be exposed to a small amount of radioactivity from the study scan. Some radioactivity will stay in your body for the first 24 hours after the scan. You should try to avoid any direct physical contact such as hugging, cuddling and sitting right next to others for the rest of the day after your tracer injection. If your partner is pregnant, you should sleep in a separate bed for that night.

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.

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

Chief Investigator

Dr Teresa Guerrero Urbano

Supported by

Comprehensive Cancer Imaging Centre - KCL
Guy's and St Thomas' NHS Foundation Trust
Kings College Hospital NHS Foundation Trust

Kings Health Partners
NIHR Clinical Research Network: Cancer
The Rosetrees Trust

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

10279

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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