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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01549379
• Other study ID #: UWO18826
• Secondary ID: 18826
• Status: Terminated
• Phase: N/A
• First received: February 24, 2012
• Last updated: October 14, 2014
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	London Regional Cancer Program	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	London Regional Cancer Program, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery		Approximately 2-6 weeks after enrollment	No