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CompletedNCT00147472Updated Jun 22, 2012

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

A Phase 3 interventional study of PET scan in addition to conventional CT imaging in Cancer of the Head and Neck, sponsored by Ontario Clinical Oncology Group (OCOG). Completed at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-22.

Sponsored by Ontario Clinical Oncology Group (OCOG) · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer of the Head and Neck

Keywords

  • Head and neck
  • Cancer
  • Diagnosis
  • Fluorodeoxyglucose
  • Positron-Emission Tomography
  • PET
  • Oncology
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 400 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Ontario Clinical Oncology Group (OCOG) is the lead sponsor of 56 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Other
    PET

    All patients receive PET scan and conventional CT imaging.

    Other: PET scan in addition to conventional CT imaging

Interventions

  • OtherPET scan in addition to conventional CT imaging

    PET scans, Pre and post radiation treatment

    Also known as: FDG PET

06

What researchers measure

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

07

Study locations

4 sites
  • Juravinski Cancer Centre
    Hamilton, Ontario L8V 5C2, Canada
  • London Regional Cancer Centre
    London, Ontario N6A 4L6, Canada
  • Ottawa Regional Cancer Centre
    Ottawa, Ontario K1H 1C4, Canada
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00147472
Lead sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care
Responsible party
Sponsor
First posted
Sep 7, 2005
Start date
May 2004
Primary completion
Aug 2009
Completion
May 2011
Last update
Jun 22, 2012

Study contacts

John Waldron, MD
study chair · Princess Margaret Hospital, Canada
Ralph Gilbert, MD
principal investigator · Princess Margaret Hospital, Canada
Libni Eapen, MD
principal investigator · Ottawa Regional Cancer Centre
Anne Keller, MD
principal investigator · Princess Margaret Hospital, Canada
Mark N Levine, MD
principal investigator · Ontario Clinical Oncology Group (OCOG)
Bayardo Perez-Ordonez, MD
principal investigator · Princess Margaret Hospital, Canada
Chu-Shu Gu, M.Sc.
principal investigator · Ontario Clinical Oncology Group (OCOG)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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