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

NCT ID: NCT01549379

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-08-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Dynamic Contrast Enhanced CT scan

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Dynamic Contrast Enhanced CT scan

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Regional Cancer Program, Canada

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

David Palma

Radiation Oncologist/Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Palma, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program

Locations

London Regional Cancer Program

London, Ontario, Canada

Countries

Canada

Other Identifiers

18826

Identifier Type: OTHER

Identifier Source: secondary_id

UWO18826

Identifier Type: -

Identifier Source: org_study_id