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| Tracking Information | |||||||||||||||||||||||||||||
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| First Received Date ICMJE | September 1, 2005 | ||||||||||||||||||||||||||||
| Last Updated Date | April 8, 2009 | ||||||||||||||||||||||||||||
| Start Date ICMJE | May 2004 | ||||||||||||||||||||||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Ability of PET compared to CT in identifying the presence of tumour in neck nodes [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Ability of PET compared to CT in identifying the presence of tumour in neck nodes | ||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00147472 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||||||||||||||||||
| Brief Title ICMJE | Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial) | ||||||||||||||||||||||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||||||||||||||||||||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||||||||||||||||||||||
| Condition ICMJE | Cancer of the Head and Neck | ||||||||||||||||||||||||||||
| Intervention ICMJE | Other: PET scan in addition to conventional CT imaging | ||||||||||||||||||||||||||||
| Study Arms / Comparison Groups | Other: All patients receive PET scan and conventional CT imaging. | ||||||||||||||||||||||||||||
| Publications * | |||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||||||||||||||||||||||
| Estimated Completion Date | May 2011 | ||||||||||||||||||||||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | 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 | ||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||
| Location Countries ICMJE | Canada | ||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||
| NCT ID ICMJE | NCT00147472 | ||||||||||||||||||||||||||||
| Responsible Party | Dr Mark Levine, Ontario Clinical Oncology Group | ||||||||||||||||||||||||||||
| Study ID Numbers ICMJE | CTA-Control-088421 | ||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Ontario Clinical Oncology Group (OCOG) | ||||||||||||||||||||||||||||
| Collaborators ICMJE | Ontario Ministry of Health and Long Term Care | ||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Ontario Clinical Oncology Group (OCOG) | ||||||||||||||||||||||||||||
| Verification Date | April 2009 | ||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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