CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 150 target
Drug / intervention
Imaging procedure +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 3
  • Adults aged 18 or over
  • New diagnosis of oropharyngeal cancer, all anatomical subsites and HPV status accepted
  • Unilateral metastatic nodes N1-N2b (HPV-negative) or N1 (HPV-positive)
Key exclusion· 7
  • Suspicious bilateral nodes on imaging
  • Previous radiotherapy or surgery to the neck
  • Second primary oropharyngeal tumours
  • Distant metastasis (e.g. lung, bone)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04498221
NCT04498221N/ARecruitingHigh MomentumUpdated 21mo ago
Long Recruiting

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

University College, London·interventional·Posted Aug 4, 2020·Updated Sep 19, 2024

In Brief

A clinical study evaluating Imaging procedure and Surgical procedure for Oropharyngeal Cancer. Currently recruiting, targeting 150 participants across 2 sites.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ARecruiting
2021202220232024202520262027
First PostedAug 4, 2020
Enrollment StartJul 7, 2022
Primary CompletionJan 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 5.9 years agoPrimary completion in 6 months

Interventions

Imaging procedureprocedure

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

Surgical procedureprocedure

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.