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Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
This study is ongoing, but not recruiting participants.
Study NCT00147472   Information provided by Ontario Clinical Oncology Group (OCOG)
First Received: September 1, 2005   Last Updated: April 8, 2009   History of Changes

September 1, 2005
April 8, 2009
May 2004
August 2009   (final data collection date for 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 ]
Ability of PET compared to CT in identifying the presence of tumour in neck nodes
Complete list of historical versions of study NCT00147472 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1.Presence of tumour at the primary site eight to ten weeks following radiation therapy.
  • 2.The change in PET signal (standard uptake value)
  • 3.Local recurrence, distant metastases and survival
 
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
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

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.

Phase III
Interventional
Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Cancer of the Head and Neck
Other: PET scan in addition to conventional CT imaging
Other: All patients receive PET scan and conventional CT imaging.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
400
May 2011
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00147472
Dr Mark Levine, Ontario Clinical Oncology Group
CTA-Control-088421
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
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
Ontario Clinical Oncology Group (OCOG)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP