Lymphatic Mapping Of Oropharyngeal Cancer
ConditionOropharyngeal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Suspicious bilateral nodes on imaging
Previous radiotherapy or surgery to the neck
Second primary oropharyngeal tumours
Distant metastasis (e.g. lung, bone)
Trial design
Design model
Parallel
Treatments tested in this trial
Imaging procedure
Procedure/SurgeryDuring 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 procedure
Procedure/SurgeryExcision of contralateral nodes identified on imaging \*(fhSPECT or SPECT/CT\*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Imaging PhaseExperimental treatment 1 intervention
Group B: Surgical PhaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of contralateral drainage
Rate of contralateral drainage
Time frame
24 hours post injection2
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
Time frame
24 hours post injection3
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
Time frame
24 hours post injection4
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.
Time frame
24 hours post injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov