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

This study has been terminated.
(Poor Accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549379
First Posted: March 9, 2012
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
  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
Intervention Model: Parallel Assignment
Masking: None (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 David Palma, 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 ]

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 ]

Enrollment: 1
Study Start Date: July 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549379


Locations
Canada, Ontario
London Regional Cancer Program
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

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 ( Other Identifier: REB )
First Submitted: February 24, 2012
First Posted: March 9, 2012
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by David Palma, 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