Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study

Lawson Health Research Institute1 site in 1 country1 target enrollmentJuly 2013

ConditionsHead and Neck Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: Lawson Health Research Institute
Enrollment: 1
Locations: 1
Primary Endpoint: Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

For patients undergoing treatment for head and neck cancer, this study will use dynamic contrast-enhanced CT scans to try to determine which lymph nodes in the neck contain cancer and require surgical removal.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lawson Health Research Institute

Responsible Party

Principal Investigator

David Palma

Radiation Oncologist/Clinician Scientist

Lawson Health Research Institute

Eligibility Criteria

Inclusion Criteria

•Age 18 or older
•Willing to provide informed consent
•ECOG performance status 0-2
•Histologically confirmed squamous cell carcinoma (includes variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS) of the head and neck
•Tumor stage: Any (T1-T4)
•Nodal stage:
•N2 or N3 (≥ 3 cm) on pre-treatment imaging for radiotherapy cohort (higher likelihood of requiring neck dissection);
•N1-N3 for surgery cohort. N0 admissible for T4 tumors.
•Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon), with recommendation for definitive chemoradiation therapy (n=15) or surgery (n=15)

Exclusion Criteria

•Prior history of head and neck cancer within 5 years
•Prior head and neck radiation at any time
•Metastatic disease, or imaging findings suspicious for metastases
•Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer.
•Pregnant or lactating women
•Contraindication to DCE-CT (e.g. contrast allergy)