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Lymphatic Mapping Of Oropharyngeal Cancer

NCT04498221 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Oropharyngeal Cancer

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.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University College, London

    lead OTHER

Principal Investigators

  • Clare Schilling · University College, London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498221 on ClinicalTrials.gov