Lymphatic Mapping Of Oropharyngeal Cancer (LOOC)
What is the purpose of this study?
We think that a new imaging and surgical procedure may help to find out how cancer cells spread from tumours at the back of the mouth & throat to lymph glands in the neck in patients with oropharyngeal cancer.
We hope that this study will help us understand more about the pattern of spread of cancer, and help doctors decide where to direct treatment, and prevent unnecessary treatment of both sides of the neck instead of one side for future patients.
Why is this research being done?
This research is evaluating a new handheld scanner, called freehand SPECT, for detecting ‘sentinel’ lymph nodes, which are the first lymph nodes where cancer cells are likely to spread. Patients will receive a very low dose of radioactive tracer, injected into the tumour during routine examination under anaesthetic (EUA). The handheld scanner will then be used to detect sentinel lymph nodes. Patients will also undergo a conventional SPECT/CT scan within 24 hours, to verify the handheld scanner’s accuracy in identifying sentinel nodes.
For some patients whose tumours are easily accessible without general anaesthesia, the same radiotracer will be injected under local anaesthetic in an outpatient clinic (instead of during EUA), 4-10 days after the initial injection, followed by SPECT/CT. Patients will be asked to complete a questionnaire on how the experience compared to the procedure under general anaesthetic. If acceptable, this could allow time for sentinel node identification by SPECT/CT prior to EUA. This means that the patient will receive more accurate information about whether the cancer has spread to sentinel nodes on the opposite side of the neck, without having to undergo additional general anaesthetic as these sentinel nodes can then be surgically removed during EUA.
What are the benefits of taking part in the study?
The information learned from this study will provide more accurate information on how cancer cells spread from the back of mouth and throat. This will help us to improve treatment in the future for people with oropharyngeal cancer and help decide whether to treat both sides of the neck.
Who is being included in the study?
We are planning to enrol 150 adults, aged 18 or over, with a new diagnosis of oropharyngeal cancer. All subsites of oropharyngeal cancer in the back of the mouth or throat are accepted, as well as both positive or negative human papilloma virus (HPV) status.
What is the status of the study?
The LOOC study is currently recruiting patients.
Who is carrying out the study?
The study is being conducted by University College London, who is the sponsor of the research. The study is funded by the National Institute for Health Research, United Kingdom.
If I have any questions, who can I contact?
If you have any questions please speak to your hospital medical team. You can also contact us by email at ncita.looc@ucl.ac.uk
For more information see the LOOC study record on ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05020522