Study Title: Lymphatic mapping Of Oropharyngeal Cancer
Cancer at the back of the mouth and throat is usually only discovered after it has spread to lymph glands in the neck. This means that both the original tumour and the cancer that has spread needs to be treated. Doctors need to decide whether to treat just one side of the neck or to treat both as the cancer may have spread to both sides or may be likely to spread to another side in the future. They base this decision on things such as how aggressive the cancer is, whether the patient smokes and whether the HPV virus is present.
This is a difficult decision which can mean some patients get treatment on both sides of the neck that they may not need, which can result in lasting problems with swallowing, and others receive treatment on one side only to have the cancer return on the other. This study hopes to give doctors more accurate information on whether to treat one side or two.
This will be done using a procedure called Sentinel Node Biopsy (SNB) to see whether or not the cancer has spread to the other side of the neck. The first part of the study is the imaging part where a radioactive substance called ‘Lymphoseek’ will be injected into the tumour. This substance quickly moves into the lymph nodes and those to which it moves first are the sentinel nodes. A handheld detector called a gamma camera can be used to detect where these are. As part of standard care patients are examined under anaesthesia (EUA) and when this happens patients in the study will have Lymphoseek injected into these sentinel nodes. To make sure the gamma camera has identified the correct nodes the patients will have a CT scan the next day.
Part two of the study is the surgery part. This will involve a new group of patients who will have the same imaging procedure. Those patents with sentinel nodes in the other side of the neck will have them removed during the EUA and these nodes will be examined for signs of cancer. Some patients in this part, those who have easily accessible tumours, will have their tumour injected with Lymphoseek under local anaesthetic a few days after their original injection. If this is acceptable to patients it could mean that we could reduce the number or visits and general anaesthetics that they receive.
If this study is successful we will have found a way to give doctors much better, more accurate information on what treatment to give and also speed up the time that it takes for patients to go through the treatment process.
Sponsor: University College London
Funder: National Institute of Health and Research
Clintrial.gov identifier : To follow