Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147472
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2005-09-01
Brief Title:
Positronic Emission Tomography PET Imaging in Post Radiation Evaluation of Head and Neck Tumours PET PREVENT Trial
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor magnetic resonance imaging MRI cannot reliably predict who is post-radiation disease free
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 andor magnetic resonance imaging MRI cannot reliably predict who is post-radiation disease free
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None