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

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

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: Dynamic Contrast Enhanced CT scan

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A4L6
      • London Regional Cancer Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical patients; 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; 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.
Active Comparator: Chemoradiation Patients; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: London Regional Cancer Program, Canada
• Investigators: Principal Investigator: David A Palma, MD, MSc, PhD, London Regional Cancer Program

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Surgery; Chemotherapy; Head and neck cancer; Radiation; Dynamic contrast enhanced computed tomography
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: UWO18826; 18826 (Other Identifier: REB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No