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| ID | Type | Description | Link |
|---|---|---|---|
| 20-5607 | Other Identifier | UHN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT-CT | Diagnostic Test | 99m-Technetium Sulfur Colloid will be injected prior to the scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John de Almeida, M.D. | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada | ||
| London Health Sciences Centre |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| London |
| Ontario |
| N6A 5W9 |
| Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |