Clinical trial · Interventional
Lymphatic Mapping Of Oropharyngeal Cancer
Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer
NCT04498221CI-TRIAL-00080565LOOCrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging procedure | Procedure | — | UNRESOLVED |
| Surgical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imaging Phase
- description
- 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
- interventionNames
- Procedure: Imaging procedure
- type
- EXPERIMENTAL
- label
- Surgical Phase
- description
- 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.
- interventionNames
- Procedure: Surgical procedure
Primary outcomes (6)
- measure
- Rate of contralateral drainage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSchilling 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