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Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)

This study is currently recruiting participants.
Study NCT00147472.   Last updated on September 11, 2008.   Information provided by Ontario Clinical Oncology Group (OCOG)

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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.

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 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 ]
Condition  Cancer of the Head and Neck
Intervention  Other: PET scan in addition to conventional CT imaging
MEDLINE PMIDs
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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:

  1. Histological evidence of squamous cell carcinoma of the head & neck (T1-T4 arising in either the oral cavity, larynx & pharynx, except Nasopharyngeal carcinoma);OR patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). Clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). Patients of Asian or African decent -possible nasopharynx primary; iii). Patients whose malignant adenopathy is confined to zone V -possible nasopharynx primary; and iv). Patients whose malignant adenopathy is confined to zone IV (supraclavicular)-possible lung primary.
  2. Presence of advanced N2 or N3 neck disease.
  3. Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.

Exclusion Criteria:

  1. Presence of distant metastasis
  2. Recurrent tumour
  3. Prior neo-adjuvant chemotherapy
  4. Previous radiation therapy to intended treatment volumes
  5. Other active malignancy
  6. Surgically inoperable neck disease
  7. Unable to remain supine for 60 minutes
  8. Unfit to undergo general anesthetic or neck dissection for medical reasons
  9. Known hypersensitivity to CT contrast
  10. Pregnancy
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Denise H Julian, M.Sc.     905 527 2299 ext 42797     juliand@mcmaster.ca    
Contact: Sharon Nason     905 527 2299 ext 42622     nasons@mcmaster.ca    
Location Countries  Canada
Administrative Information Fields
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 
Study Chair:     John Waldron, MD     Princess Margaret Hospital, Canada    
Principal Investigator:     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    
Principal Investigator:     Bayardo Perez-Ordonez, MD     Princess Margaret Hospital, Canada    
Principal Investigator:     Chu-Shu Gu, M.Sc.     Ontario Clinical Oncology Group    
Information Provided By Ontario Clinical Oncology Group (OCOG)
Verification Date September 2008
First Received Date  September 1, 2005
Last Updated Date September 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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