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

Lawson Health Research Institute

Status: Terminated

Conditions: Head and Neck Cancer

Treatments: Radiation: Dynamic Contrast Enhanced CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT01549379

UWO18826

18826 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Surgical patients

Active Comparator group

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.

Treatment:

Radiation: Dynamic Contrast Enhanced CT scan

Chemoradiation Patients

Active Comparator group

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.

Treatment:

Radiation: Dynamic Contrast Enhanced CT scan