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Completed

NCT Number: NCT05055206

Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

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.

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Key information

Conditions

Oropharynx Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPECT-CT

Diagnostic Test

99m-Technetium Sulfur Colloid will be injected prior to the scan.

Primary outcomes

  1. Proportion of patients injected with radiotracer.

    Time frame: 1 year

  2. Proportion of patients requiring general anesthetic over local anesthetic.

    Time frame: 1 year

  3. Proportion of patients with images that failed radiotracer migration to either side of the neck.

    Time frame: 1 year

  4. Proportion of patients completing 30 minute scan.

    Time frame: 1 year

  5. Proportion of patients completing 3 hour scan.

    Time frame: 1 year

  6. Proportion of patients with radiotracer uptake into a radiographically positive lymph node.

    Time frame: 1 year

  7. Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.

    Time frame: 1 year

  8. Average time from start to finish of injection of procedure.

    Time frame: 1 year

  9. Proportion of patients with complications associated with injection.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2021
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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