At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Imaging procedure (procedure), Surgical procedure (procedure)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Imaging procedure — procedure: During routine examination under anaesthetic 4 x peritumoural injection of investigator's choice of 99mTc-human albumin colloidal particles or Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan · Surgical procedure — procedure: Excision of contralateral nodes identified on imaging \*(fhSPECT or SPECT/CT\*) during routine examination under anaesthetic.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 150
- Started
- 2022-07-07
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for oropharyngeal cancer
- • NA - 150 participants
- • A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current gold standard in identifying sentinel nodes in patients with oropharyngeal cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with oropharyngeal cancer
Where?
- • London - St George's University Hospitals NHS Foundation Trust
- • London - University College Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A multi-centre validation study to evaluate whether a new imaging and surgical protocol would work as well as the current gold standard in identifying sentinel nodes in patients with oropharyngeal cancer.
More detail
Cancer at the back of the mouth and throat is usually discovered after it has spread to lymph glands in the neck. Treatment therefore involves dealing with both the original tumour (in the mouth/throat) and the spread cancer in the lymph glands. This type of cancer sometimes spreads to both sides of the neck, not just the side on which the original tumour was located. The decision as to whether to treat the other side of the neck as well depends on various factors including the aggressiveness of the tumour, whether the patient smokes and whether or not the Human Papilloma Virus (HPV) is present in the tumour. This is inevitably inexact, and assessing the likelihood of the cancer spreading to the other side of the neck always involves an element of estimation. Some patients end up being treated unnecessarily on both sides (often with severe and lasting effects on swallowing, meaning they have to use a feeding tube), while others receive treatment on one side only but the cancer comes back on the other side. This study will provide more accurate information on which to base the decision as to whether to treat the other side of the neck. The study will use a procedure known as sentinel node biopsy (SNB) to establish (with a high degree of accuracy) whether or not the cancer has spread to the other side of the neck. The study will be in two stages. The first stage is the imaging stage. A very low does of a radioactive tracer substance will be injected into the tumour. The radioactive tracers used in this study are either Human albumin colloidal particles or Lymphoseek. Once injected, they move quickly into the lymph nodes and can then be detected using a handheld gamma camera. The first nodes that the radiotracer moves into are the "sentinel" nodes. Patients already undergo an examination under anaesthetic (EUA); the patients participating in the study will have the radiotracer injected additionally and the sentinel nodes detected during this EUA. The use of the handheld camera is relatively new; so, all of the patients in the study will also have a CT scan the next day to double check whether the handheld camera identified the sentinel nodes correctly. The second stage of the study, the surgery stage, will involve a new group of patients having the imaging procedure. Those who do have sentinel nodes in the other side of the neck will have them removed during the EUA. Those nodes will then be examined thoroughly for signs of cancer. A separate limb of stage one of the study will involve some patients whose main tumours are easily accessible also having their tumour injected with the radiotracer a second time under local anaesthetic in an outpatient clinic. In the study this will take place several days after the initial injection with the radiotracer. If this procedure is found to be acceptable to patients, it would mean that patients could have the radiotracer injected before the EUA, thereby allowing time for the sentinel nodes to be identified by CT scan so that they can be removed during the EUA. This will provide a way to ensure that, even if the handheld camera cannot be used, the sentinel nodes can still be removed while the patient is under anaesthetic for the EUA. If the study is successful, the patient will be able to have much more accurate information about whether their cancer has, or might, spread to the other side of the neck, without having to undergo an additional general anaesthetic.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adults aged 18 or over
- ✓New diagnosis of OPC - all anatomical subsites and HPV status accepted
- ✓Unilateral that has spread nodes equating to AJCC TNM8 clinical staging N1-N2b for P16 negative and N1 for P16 positive...
Who cannot take part
- ✗Suspicious bilateral nodes on imaging
- ✗Previous radiotherapy or surgery to the neck
- ✗Second primary oropharyngeal tumours
- ✗Distant metastasis (e.g. lung, bone)
- ✗Pregnancy and lactation
See the full criteria
Where Is This Study? (2 UK sites)
St George's University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
University College Hospital
London, United Kingdom
How to Get in Touch
Trial Manager
Sponsor contactCONTACT
