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

This study is not yet open for participant recruitment.
Verified March 2012 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: March 6, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

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: March 2012
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.
  Contacts and Locations
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 Not yet 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: March 6, 2012
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 May 21, 2013