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NCT Number: NCT00147472

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Juravinski Cancer Centre, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All of the following criteria must be satisfied:

  • 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.
  • Presence of advanced N2 or N3 neck disease.
  • Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.

Exclusion criteria

  • Presence of distant metastasis
  • Recurrent tumour
  • Prior neo-adjuvant chemotherapy
  • Previous radiation therapy to intended treatment volumes
  • Other active malignancy
  • Surgically inoperable neck disease
  • Unable to remain supine for 60 minutes
  • Unfit to undergo general anesthetic or neck dissection for medical reasons
  • Known hypersensitivity to CT contrast
  • Pregnancy

Treatment and study plan

PET scan in addition to conventional CT imaging

Other

PET scans, Pre and post radiation treatment

Other names: FDG PET

Primary outcomes

  1. Ability of PET compared to CT in identifying the presence of tumour in neck nodes

    Time frame: 2 years

Secondary outcomes

  1. Tumour at the primary site 8-10 weeks following radiation;

    Time frame: 2 years

  2. The change in PET signal (standard uptake value;

    Time frame: 2 years

  3. Local recurrence, distant metastases and survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2009
Study completion
2011
First posted
Sep 7, 2005
Registry last updated
Jun 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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