Mapping lymph nodes in oropharyngeal cancer patients
Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer
This study is testing a new way to find important lymph nodes in patients with oropharyngeal cancer to see if it can help doctors make better treatment choices and avoid unnecessary side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT04498221 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new imaging and surgical protocol for identifying sentinel nodes in patients with oropharyngeal cancer, aiming to improve treatment decisions. It involves a two-stage process where a radioactive tracer is injected into the tumor to enhance the accuracy of sentinel node biopsy. By determining whether cancer has spread to the other side of the neck, the study seeks to reduce unnecessary treatments and their associated side effects. The study is conducted across multiple centers to validate the effectiveness of this new approach compared to the current gold standard.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or over with a new diagnosis of oropharyngeal cancer and unilateral metastatic nodes.
Not a fit: Patients with suspicious bilateral nodes, previous neck surgery or radiotherapy, or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more precise treatment decisions, reducing unnecessary surgeries and improving patient quality of life.
How similar studies have performed: Other studies have shown promise in using sentinel node biopsy for various cancers, suggesting potential success for this approach in oropharyngeal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 or over * New diagnosis of OPC - all anatomical subsites and HPV status accepted * Unilateral metastatic nodes equating to AJCC TNM8 clinical staging N1-N2b for P16 negative and N1 for P16 positive patients. Exclusion Criteria: * 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 * Inability to give informed consent * Allergy to lymphatic tracers
Where this trial is running
London and 1 other locations
- St George's University Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- University College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Clare Schilling — University College, London
- Study coordinator: Trial Manager
- Email: ncita.looc@ucl.ac.uk
- Phone: 02076799274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.