Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

NCT ID: NCT05055206

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-13
• Study Completion Date: 2023-10-31

Brief Summary

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

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.

Conditions

Oropharynx Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

SPECT-CT

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

SPECT-CT

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John de Almeida, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

20-5607

Identifier Type: OTHER

Identifier Source: secondary_id

SPECT-CT

Identifier Type: -

Identifier Source: org_study_id