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.

Study Overview

• Status: Completed
• Conditions: Cancer of the Head and Neck
• Intervention / Treatment: Other: PET scan in addition to conventional CT imaging

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: FDG PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ability of PET compared to CT in identifying the presence of tumour in neck nodes	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumour at the primary site 8-10 weeks following radiation;	2 years
The change in PET signal (standard uptake value;	2 years
Local recurrence, distant metastases and survival	2 years

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Principal Investigator: Mark N Levine, MD, Ontario Clinical Oncology Group (OCOG); 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: Bayardo Perez-Ordonez, MD, Princess Margaret Hospital, Canada; Principal Investigator: Chu-Shu Gu, M.Sc., Ontario Clinical Oncology Group (OCOG)

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 1, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (Estimate): September 7, 2005

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 20, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Cancer; PET; Diagnosis; Oncology; Positron-Emission Tomography; Head and neck; Fluorodeoxyglucose
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CTA-Control-088421