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| Descriptive Information Fields | |||||||||||||||||||||||||||||
| Brief Title † | Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial) | ||||||||||||||||||||||||||||
| Official Title † | A Prospective Cohort Study to Determine the Sensitivity of Positron Emission Tomography (PET) in Detecting Metastatic Cancer in Neck Lymph Nodes in Patients With Squamous Cell Head & Neck Cancer Managed With Primary Radiation Therapy | ||||||||||||||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase III | ||||||||||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||||||||||||||||||||||
| Primary Outcome Measure † | Ability of PET compared to CT in identifying the presence of tumour in neck nodes [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||
| Secondary Outcome Measure † | Tumour at the primary site 8-10 weeks following radiation; [ Time Frame: 2 years ] [ Designated as safety issue: No ] The change in PET signal (standard uptake value; [ Time Frame: 2 years ] [ Designated as safety issue: No ] Local recurrence, distant metastases and survival [ Time Frame: 2 years ] [ Designated as safety issue: No ] |
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| Condition † | Cancer of the Head and Neck | ||||||||||||||||||||||||||||
| Intervention † | Other: PET scan in addition to conventional CT imaging | ||||||||||||||||||||||||||||
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| Recruitment Information Fields | |||||||||||||||||||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||||||||||||||||||
| Enrollment † | 400 | ||||||||||||||||||||||||||||
| Start Date † | May 2004 | ||||||||||||||||||||||||||||
| Completion Date | May 2011 | ||||||||||||||||||||||||||||
| Eligibility Criteria † | Inclusion Criteria: All of the following criteria must be satisfied:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||
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| Location Countries † | Canada | ||||||||||||||||||||||||||||
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| NCT ID † | NCT00147472 | ||||||||||||||||||||||||||||
| Organization ID | CTA-Control-088421 | ||||||||||||||||||||||||||||
| Secondary IDs †† | |||||||||||||||||||||||||||||
| Study Sponsor † | Ontario Clinical Oncology Group (OCOG) | ||||||||||||||||||||||||||||
| Collaborators †† | Ontario Ministry of Health and Long Term Care | ||||||||||||||||||||||||||||
| Investigators † |
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| Information Provided By | Ontario Clinical Oncology Group (OCOG) | ||||||||||||||||||||||||||||
| Verification Date | September 2008 | ||||||||||||||||||||||||||||
| First Received Date † | September 1, 2005 | ||||||||||||||||||||||||||||
| Last Updated Date | September 11, 2008 | ||||||||||||||||||||||||||||