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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer of the Head and Neck

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

John Waldron, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

CTA-Control-088421

NCT ID:

NCT00147472

Start Date:

May 2004

Completion Date:

May 2011

Related Keywords:

  • Cancer of the Head and Neck
  • Head and neck
  • Cancer
  • Diagnosis
  • Fluorodeoxyglucose
  • Positron-Emission Tomography
  • PET
  • Oncology
  • Head and Neck Neoplasms

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