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

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00147472
First received: September 1, 2005
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer of the Head and Neck
 Other: PET scan in addition to conventional CT imaging
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 400
Study Start Date: May 2004
Study Completion Date: May 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET
All patients receive PET scan and conventional CT imaging.
 Other: PET scan in addition to conventional CT imaging
PET scans, Pre and post radiation treatment
Other Name: FDG PET

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147472

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
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 (OCOG)
Principal Investigator: Bayardo Perez-Ordonez, MD Princess Margaret Hospital, Canada
Principal Investigator: Chu-Shu Gu, M.Sc. Ontario Clinical Oncology Group (OCOG)
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00147472     History of Changes
Other Study ID Numbers: CTA-Control-088421
Study First Received: September 1, 2005
Last Updated: June 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Head and neck
Cancer
Diagnosis
Fluorodeoxyglucose
 Positron-Emission Tomography
PET
Oncology

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013