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Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

Primary Purpose

Oropharynx Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SPECT-CT
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oropharynx Cancer focused on measuring Lymphatic Drainage Mapping, 99m-Technetium Sulfur Colloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting
  • London Health Sciences CentreRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • Princess Margaret Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lymphatic drainage mapping in patients with oropharynx cancer

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
June 15, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05055206
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Cancer
Keywords
Lymphatic Drainage Mapping, 99m-Technetium Sulfur Colloid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lymphatic drainage mapping in patients with oropharynx cancer
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
SPECT-CT
Intervention Description
99m-Technetium Sulfur Colloid will be injected prior to the scan.
Primary Outcome Measure Information:
Title
Proportion of patients injected with radiotracer.
Time Frame
1 year
Title
Proportion of patients requiring general anesthetic over local anesthetic.
Time Frame
1 year
Title
Proportion of patients with images that failed radiotracer migration to either side of the neck.
Time Frame
1 year
Title
Proportion of patients completing 30 minute scan.
Time Frame
1 year
Title
Proportion of patients completing 3 hour scan.
Time Frame
1 year
Title
Proportion of patients with radiotracer uptake into a radiographically positive lymph node.
Time Frame
1 year
Title
Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations.
Time Frame
1 year
Title
Average time from start to finish of injection of procedure.
Time Frame
1 year
Title
Proportion of patients with complications associated with injection.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John de Almeida, M.D.
Phone
416-946-4501
Ext
2149
Email
John.deAlmeida@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John de Almeida, M.D.
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Zhang, MD
Phone
905-522-1155
Ext
37031
Email
Hanzhang@stjosham.on.ca
First Name & Middle Initial & Last Name & Degree
Han Zhang, MD
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle MacNeil, MD
Phone
519-685-8767
Email
Danielle.Macneil@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Danielle MacNeil, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Eskander, MD
Phone
416-480-6705
Email
Antoine.Eskander@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Antoine Eskander, MD
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John de Almeida, M.D.
Phone
416-946-4501
Ext
2149
First Name & Middle Initial & Last Name & Degree
John de Almeida, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

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