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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Lawson Health Research Institute
Sponsor:
Collaborator:
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01549379
First received: February 24, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Radiation: Dynamic Contrast Enhanced CT scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy [ Time Frame: 8-10 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery [ Time Frame: Approximately 2-6 weeks after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549379

Contacts
Contact: David A Palma, MD, MSc, PhD 519-685-8500 ext 53347 david.palma@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A4L6
Sponsors and Collaborators
Lawson Health Research Institute
London Regional Cancer Program, Canada
Investigators
Principal Investigator: David A Palma, MD, MSc, PhD London Regional Cancer Program
  More Information

No publications provided

Responsible Party: David Palma, Radiation Oncologist/Clinician Scientist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01549379     History of Changes
Other Study ID Numbers: UWO18826, 18826
Study First Received: February 24, 2012
Last Updated: January 14, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Head and neck cancer
Radiation
Chemotherapy
Surgery
Dynamic contrast enhanced computed tomography

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 09, 2014