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

NCT00147472 | Completed Phase 3 DMC

• 1 other identifier: CTA-Control-088421
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer of the Head and Neck

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (3)

• 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

Study Arms (1)

PET

OTHER

All patients receive PET scan and conventional CT imaging.

Other: PET scan in addition to conventional CT imaging

Interventions

PET scan in addition to conventional CT imaging OTHER

PET scans, Pre and post radiation treatment

Also known as: FDG PET

PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (4)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms; Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• John Waldron, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 7, 2005
• Study Start: May 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2011
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

CA (4)