Lymphatic Mapping Of Oropharyngeal Cancer
LOOC
Prospective, Multi-Centre, Phase II Validation Study for a Lymphatic Imaging Protocol in Establishing Drainage Patterns in Patients With Oropharyngeal Cancer
1 other identifier
interventional
150
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedStudy Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
September 19, 2024
September 1, 2024
4.5 years
December 4, 2019
September 11, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Rate of contralateral drainage
Rate of contralateral drainage
24 hours post injection
Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
Accuracy of detection of contralateral nodes by lymphoscintigraphy using fhSPECT compared to SPECT/CT
24 hours post injection
Number of contralateral nodes on SPECT/CT
Number of contralateral nodes on SPECT/CT will be used as the denominator in calculating the sensitivity of fhSPECT in independently verified images
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.
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.
24 hours post injection
Acceptability to patients assessed by questionnaire.
Acceptability to patients assessed by questionnaire.
24 hours post injection
Occult metastasis rate of contralateral nodes (positive sentinel node biopsy).
Occult metastasis rate of contralateral nodes (positive sentinel node biopsy).
24 hours post injection
Study Arms (2)
Imaging Phase
EXPERIMENTALDuring 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 Phase
EXPERIMENTALExcision of contralateral nodes identified on imaging \*(fhSPECT or SPECT/CT\*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
University College Hospital
London, United Kingdom
Related Publications (1)
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: 40473291DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clare Schilling
University College, London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2019
First Posted
August 4, 2020
Study Start
July 7, 2022
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
No identifiable data will be shared with anyone outside the study