Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

University Health Network, Toronto

Status: Completed

Conditions: Oropharynx Cancer

Treatments: Diagnostic Test: SPECT-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05055206

SPECT-CT

20-5607 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Lymphatic drainage mapping in patients with oropharynx cancer

Experimental group

Description:

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).

Treatment:

Diagnostic Test: SPECT-CT