PET/CT to Image Hypoxia in Head and Neck Tumours

NCT00395109 | Completed Early Phase 1

• 2 other identifiers: R-06-37012660
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with head and neck cancer will be imaged with PET scan and CT scan in order to determine areas of the tumour that are hypoxic. It is hypothesized that PET /CT will provide information on hypoxia of the tumors and tumor regions in head and neck cancer patients.

Conditions

Head and Neck Cancer

Keywords

cancer; hypoxia; PET scan; CT scan

Outcome Measures

Primary Outcomes (2)

• FDG/PET visualization of glycolysis/blood flow in tumors and intra-tumor regions;

  2 years

• Measurement of mRNAs levels encoding hypoxia response genes in tumor samples.

  2 years

Interventions

PET/CT DEVICE

All study participates will be scanned with PET/CT scan before surgery.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with head and neck tumours (\>3cm diameter) without bone involvement.

You may not qualify if:

• Known allergy to contrast agents
• Poor kidney function (serum creatinine level \> 2.0 mg/dL or 177 mmol/L)
• Pregnancy
• Breast-feeding
• Unable to lie supine
• Patient who were biopsied or operated upon within the past month.
• Patient who were treated with chemotherapy or radiation within the past month.
• Tumors that were obscured by artifacts (e.g. tooth fillings) in CT scans.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Science Center

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms; Hypoxia

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• John Yoo, MD

  Dept. of Otolaryngology, London Health Science Center, London, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: November 8, 2006
• Primary Completion: November 30, 2009
• Study Completion: December 31, 2009
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)