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

Not Applicable

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Radiation: Dynamic Contrast Enhanced CT scan

• 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

Study Timeline

• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Study Start: 2013-07
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

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

Arm && Interventions

Group	Intervention	Description
Chemoradiation Patients	Dynamic Contrast Enhanced CT scan	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.
Surgical patients	Dynamic Contrast Enhanced CT scan	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery	Approximately 2-6 weeks after enrollment

Trial Locations

Locations (1)

London Regional Cancer Program; 🇨🇦 London, Ontario, Canada