Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

Oropharynx Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055206
• Other study ID #: SPECT-CT
• Secondary ID: 20-5607
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 31, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• Oropharynx Cancer

Intervention

Diagnostic Test:
• SPECT-CT
99m-Technetium Sulfur Colloid will be injected prior to the scan.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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