Clinical trial NCT05055206: Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers
Official title: A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharynx Cancer
Keywords: Lymphatic Drainage Mapping
99m-Technetium Sulfur Colloid
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of patients injected with radiotracer.
timeFrame: 1 year
measure: Proportion of patients requiring general anesthetic over local anesthetic.
timeFrame: 1 year
measure: Proportion of patients with images that failed radiotracer migration to either side of the neck.
timeFrame: 1 year
measure: Proportion of patients completing 30 minute scan.
timeFrame: 1 year
measure: Proportion of patients completing 3 hour scan.
timeFrame: 1 year
measure: Proportion of patients with radiotracer uptake into a radiographically positive lymph node.
timeFrame: 1 year
measure: Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.
timeFrame: 1 year
measure: Average time from start to finish of injection of procedure.
timeFrame: 1 year
measure: Proportion of patients with complications associated with injection.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: John de Almeida, M.D.
role: PRINCIPAL_INVESTIGATOR
References: