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

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Radiation: Dynamic Contrast Enhanced CT scan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical patients<br>This group will consist of 15 patients with locally advanced HNSCC of the oral cavity, larynx or hypopharynx presenting with adenopathy ≥ 1 cm where the recommended treatment is surgical resection of the primary malignancy with bilateral neck dissection. These patients will receive a DCE-CT scan of the head and neck prior to surgery. | Radiation: Dynamic Contrast Enhanced CT scan<br>* The neck will be scanned using 120 kVp, 50 mAs, 8 x 5 mm slices at intervals of 2.8 - 3.0 s for 3 min. Contrast (e.g. Visipaque 320) at a dosage of 0.7 ml/kg is injected at 4 ml/s through an antecubital vein after a delay of 6 s from start of scanning.<br>|
| Active Comparator: Chemoradiation Patients<br>This group will consist of 15 patients with locally advanced HNSCC with lymph nodes ≥3 cm in which chemoradiotherapy is the primary treatment as per standard of care. This group will be composed of patients with a primary malignancy originating in the nasopharynx, oropharynx, hypopharynx or larynx. Pre-treatment DCE-CT of neck will be obtained. The standard therapy, radiation and chemotherapy, will be administered and the patients will have standard follow up. A post-treatment DCE-CT of neck will be obtained 8-10 weeks after treatment along with standard CT neck. | Radiation: Dynamic Contrast Enhanced CT scan<br>* The neck will be scanned using 120 kVp, 50 mAs, 8 x 5 mm slices at intervals of 2.8 - 3.0 s for 3 min. Contrast (e.g. Visipaque 320) at a dosage of 0.7 ml/kg is injected at 4 ml/s through an antecubital vein after a delay of 6 s from start of scanning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy |  | 8-10 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery |  | Approximately 2-6 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and neck cancer, Radiation, Chemotherapy, Surgery, Dynamic contrast enhanced computed tomography