NCT05055206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

September 14, 2021

Last Update Submit

November 25, 2025

Conditions

Oropharynx Cancer

Keywords

Lymphatic Drainage Mapping99m-Technetium Sulfur Colloid

Outcome Measures

Primary Outcomes (9)

  • Proportion of patients injected with radiotracer.

    1 year

  • Proportion of patients requiring general anesthetic over local anesthetic.

    1 year

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

    1 year

  • Proportion of patients completing 30 minute scan.

    1 year

  • Proportion of patients completing 3 hour scan.

    1 year

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

    1 year

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

    1 year

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

    1 year

  • Proportion of patients with complications associated with injection.

    1 year

Study Arms (1)

Lymphatic drainage mapping in patients with oropharynx cancer

EXPERIMENTAL

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

Interventions

SPECT-CTDIAGNOSTIC_TEST

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

Lymphatic drainage mapping in patients with oropharynx cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • John de Almeida, M.D.

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 24, 2021

Study Start

September 13, 2021

Primary Completion

October 23, 2023

Study Completion

October 31, 2023

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)