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Recruiting NCT04498221

Lymphatic Mapping Of Oropharyngeal Cancer

No phase Interventional Oropharyngeal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Imaging procedure, Surgical procedure.
Who it may be relevant to
Registry conditions: Oropharyngeal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer

Overview

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.

Detailed description

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.

Interventions

  • Procedure Imaging 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
  • Procedure Surgical procedure
    Excision of contralateral nodes identified on imaging \*(fhSPECT or SPECT/CT\*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.

Primary outcome measures

  • Rate of contralateral drainage [Time frame: 24 hours post injection]
  • Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT [Time frame: 24 hours post injection]
  • Number of contralateral nodes on SPECT/CT [Time frame: 24 hours post injection]
  • Number and location of contralateral nodes seen with lymphoscintigraphy performed by i) single injection ii) four peritumoural injections (standard practice) as assessed by paired SPECT/CT scans. [Time frame: 24 hours post injection]
  • Acceptability to patients assessed by questionnaire. [Time frame: 24 hours post injection]
  • Occult metastasis rate of contralateral nodes (positive sentinel node biopsy). [Time frame: 24 hours post injection]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United Kingdom · 2 centers
  • St George's University Hospitals NHS Foundation Trust — London
  • University College Hospital — London

Publications

  • Schilling C, Payne K, Wan S, Brew-Graves C, Ofo E, Ambler G, Weller A, Gnanasegaran G, Paleri V, Shaw R, Fleming J, Walker D, Bajwa M, McGurk M. Lymphatic mapping Of Oropharyngeal Cancer (LOOC): protocol for a phase II surgical imaging trial to evaluate contralateral drainage and occult metastasis in oropharyngeal cancer. BMJ Open. 2025 Jun 5;15(6):e101746. doi: 10.1136/bmjopen-2025-101746. PMID 40473291

Identifiers

NCT: NCT04498221 · 127659

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗