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| Name | Class |
|---|---|
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
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The purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck.
Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who are node positive (N2 N3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. However, currently used standard tests, like computed tomography (CT) and/or magnetic resonance imaging (MRI) cannot reliably predict who is post-radiation disease free.
PET-Fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells. PET might detect neck tumours better than other imaging tests. This is a cohort study in which patients with N2 N3 squamous cell carcinoma of the head and neck undergo a PET and a CT scan at baseline and then post-radiation therapy and chemotherapy. Then, they undergo neck dissection surgery. The PET and CT results are compared with the presence or absence of tumours in the neck nodes. If PET is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET | Other | All patients receive PET scan and conventional CT imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET scan in addition to conventional CT imaging | Other | PET scans, Pre and post radiation treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of PET compared to CT in identifying the presence of tumour in neck nodes | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour at the primary site 8-10 weeks following radiation; | 2 years | |
| The change in PET signal (standard uptake value; | 2 years | |
| Local recurrence, distant metastases and survival |
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Inclusion Criteria:
All of the following criteria must be satisfied:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Waldron, MD | Princess Margaret Hospital, Canada | Study Chair |
| Ralph Gilbert, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Libni Eapen, MD | Ottawa Regional Cancer Centre | Principal Investigator |
| Anne Keller, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Mark N Levine, MD | Ontario Clinical Oncology Group (OCOG) | Principal Investigator |
| Bayardo Perez-Ordonez, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Chu-Shu Gu, M.Sc. | Ontario Clinical Oncology Group (OCOG) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada | ||
| London Regional Cancer Centre |
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| 2 years |
| London |
| Ontario |
| N6A 4L6 |
| Canada |
| Ottawa Regional Cancer Centre | Ottawa | Ontario | K1H 1C4 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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