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

NCT01549379 | Terminated

• 2 other identifiers: UWO1882618826
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer; Radiation; Chemotherapy; Surgery; Dynamic contrast enhanced computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery

  Approximately 2-6 weeks after enrollment

Study Arms (2)

Surgical patients

ACTIVE COMPARATOR

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

Chemoradiation Patients

ACTIVE COMPARATOR

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

Interventions

Dynamic Contrast Enhanced CT scan RADIATION

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.

Chemoradiation Patients; Surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Regional Cancer Program, Canada: collaborator

Study Sites (1)

London Regional Cancer Program

London, Ontario, N6A4L6, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• David A Palma, MD, MSc, PhD

  London Regional Cancer Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist/Clinician Scientist

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 9, 2012
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

CA (1)