Back to resultsDynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dynamic Contrast Enhanced CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring Head and neck cancer, Radiation, Chemotherapy, Surgery, Dynamic contrast enhanced computed tomography
Eligibility 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)
Sites / Locations
- London Regional Cancer Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Surgical patients
Chemoradiation Patients
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy
Secondary Outcome Measures
Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery
Full Information
NCT ID
NCT01549379
First Posted
February 24, 2012
Last Updated
October 14, 2014
Sponsor
Lawson Health Research Institute
Collaborators
London Regional Cancer Program, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01549379
Brief Title
Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer
Official Title
Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Poor Accrual
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
London Regional Cancer Program, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and neck cancer, Radiation, Chemotherapy, Surgery, Dynamic contrast enhanced computed tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgical patients
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemoradiation Patients
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Dynamic Contrast Enhanced CT scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery
Time Frame
Approximately 2-6 weeks after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Palma, MD, MSc, PhD
Organizational Affiliation
London Regional Cancer Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dynamic Contrast Enhanced Computed Tomography (CT) for Head and Neck Cancer
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