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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

PET scan in addition to conventional CT imaging

About this trial

This is an interventional diagnostic trial for Cancer of the Head and Neck focused on measuring Head and neck, Cancer, Diagnosis, Fluorodeoxyglucose, Positron-Emission Tomography, PET, Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Juravinski Cancer Centre
London Regional Cancer Centre
Ottawa Regional Cancer Centre
Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET

Arm Description

All patients receive PET scan and conventional CT imaging.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

The change in PET signal (standard uptake value;

Local recurrence, distant metastases and survival

Full Information

NCT ID

NCT00147472

First Posted

September 1, 2005

Last Updated

June 20, 2012

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

1. Study Identification

Unique Protocol Identification Number

NCT00147472

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Head and Neck

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PET

Arm Type

Other

Arm Description

All patients receive PET scan and conventional CT imaging.

Intervention Type

Other

Intervention Name(s)

PET scan in addition to conventional CT imaging

Other Intervention Name(s)

FDG PET

Intervention Description

PET scans, Pre and post radiation treatment

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

The change in PET signal (standard uptake value;

Time Frame

2 years

Title

Local recurrence, distant metastases and survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: