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Study of Lymphatic Drainage Mapping in Oropharyngeal Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05055206
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Diagnostic Test: SPECT-CT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Feasibility Trial of Lymphatic Mapping With SPECT-CT for Evaluating Contralateral Disease in Lateralized Oropharynx Cancer Using 99m-Technetium Sulfur Colloid
Actual Study Start Date : September 13, 2021
Estimated Primary Completion Date : September 13, 2023
Estimated Study Completion Date : September 13, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).

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




Primary Outcome Measures :
  1. Proportion of patients injected with radiotracer. [ Time Frame: 1 year ]
  2. Proportion of patients requiring general anesthetic over local anesthetic. [ Time Frame: 1 year ]
  3. Proportion of patients with images that failed radiotracer migration to either side of the neck. [ Time Frame: 1 year ]
  4. Proportion of patients completing 30 minute scan. [ Time Frame: 1 year ]
  5. Proportion of patients completing 3 hour scan. [ Time Frame: 1 year ]
  6. Proportion of patients with radiotracer uptake into a radiographically positive lymph node. [ Time Frame: 1 year ]
  7. Proportion of patients with injections site locations that are compliant with protocol specific map of injection locations. [ Time Frame: 1 year ]
  8. Average time from start to finish of injection of procedure. [ Time Frame: 1 year ]
  9. Proportion of patients with complications associated with injection. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05055206


Contacts
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Contact: John de Almeida, M.D. 416-946-4501 ext 2149 John.deAlmeida@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: John de Almeida, M.D.    416-946-4501 ext 2149      
Principal Investigator: John de Almeida, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: John de Almeida, M.D. University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05055206    
Other Study ID Numbers: SPECT-CT
20-5607 ( Other Identifier: UHN )
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Lymphatic Drainage Mapping
99m-Technetium Sulfur Colloid
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases