Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

Study Overview
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Brief Summary
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The purpose of the study is to see how practical it is to inject a radiotracer called 99m-Technetium Sulfur Colloid around the tumors for the imaging of patients with oropharyngeal cancer.

Detailed Description
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This study will evaluate a technique called lymphatic drainage mapping. This is a technique where a radiotracer (a radioactive material that can be seen with a special computed tomography [CT] scanner to create 3D images) is injected into a vein around the tumour, either with local anesthesia or under general anesthesia. The radiotracer that will be used for the lymphatic drainage mapping is called 99m-Technetium Sulfur Colloid. Images will be taken of neck to detect the movement of the radiotracer. This will allow the doctors to see the drainage pattern of the lymph nodes in the neck. The information from this study will be used to better understand the tendency for oropharyngeal cancers to spread to lymph nodes. In addition, the information from this clinical trial will be used in future clinical studies to help specialists identify strategies to help plan treatment based on this type of imaging study.

Official Title
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A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid

Conditions
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Oropharynx Cancer

Intervention / Treatment
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* Diagnostic Test: SPECT-CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has lateralized oropharyngeal carcinoma (tonsil or tongue base) not involving midline Has squamous cell carcinoma, T1-3 tumours, with no contralateral nodes on clinical exam or axial imaging Human papillomavirus (HPV) positive or negative Patient should have normal organ function as per Investigator judgement Patient is planned for definitive or adjuvant radiotherapy (RT) or chemo radiotherapy (CRT) with bilateral neck RT, or surgery Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Exclusion Criteria: T4 tumours Contralateral/bilateral nodal disease or node(s) > 6cm on clinical exam or axial imaging or positron emission tomography (PET) Primary tumour involving or crossing midline Soft palate or posterior pharyngeal wall tumour subsites Previous head and neck cancer Previous radiotherapy (RT) to the head and neck Previous neck dissection Distant metastases Prior invasive malignancy (except non-melanoma skin cancer) unless disease free for 3 years Prior radiotracer allergy Multiple primary head and neck cancers Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphatic drainage mapping in patients with oropharynx cancer<br>Participants will be given 4 to 6 injections of the radiotracer 99m-Technetium Sulfur Colloid by a needle into one of the veins of the radiotracer around the tumour. Participants will then have at least 1 or possibly 2 SPECT-CT scans (a special x-ray scan of the body from many angles that are turned into 3-dimensional pictures on a screen). | Diagnostic Test: SPECT-CT<br>* 99m-Technetium Sulfur Colloid will be injected prior to the scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients injected with radiotracer. |  | 1 year | 
| Proportion of patients requiring general anesthetic over local anesthetic. |  | 1 year | 
| Proportion of patients with images that failed radiotracer migration to either side of the neck. |  | 1 year | 
| Proportion of patients completing 30 minute scan. |  | 1 year | 
| Proportion of patients completing 3 hour scan. |  | 1 year | 
| Proportion of patients with radiotracer uptake into a radiographically positive lymph node. |  | 1 year | 
| Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations. |  | 1 year | 
| Average time from start to finish of injection of procedure. |  | 1 year | 
| Proportion of patients with complications associated with injection. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphatic Drainage Mapping, 99m-Technetium Sulfur Colloid