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Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer

Not Applicable
Terminated
Conditions
Head and Neck Cancer
Registration Number
NCT01549379
Lead Sponsor
Lawson Health Research Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy8-10 weeks post treatment
Secondary Outcome Measures
NameTimeMethod
Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgeryApproximately 2-6 weeks after enrollment

Trial Locations

Locations (1)

London Regional Cancer Program

🇨🇦

London, Ontario, Canada

London Regional Cancer Program
🇨🇦London, Ontario, Canada

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