Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

November 25, 2025 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional 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

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: John de Almeida, M.D., University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

October 23, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECT-CT
  • 20-5607 (Other Identifier: UHN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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