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Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to Assess Lymph Node Metastases in Head and Neck Cancer: A Prospective Study


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy

Outcome Time Frame:

8-10 weeks post treatment

Safety Issue:

No

Principal Investigator

David A Palma, MD, MSc, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Regional Cancer Program

Authority:

Canada: Ethics Review Committee

Study ID:

UWO18826

NCT ID:

NCT01549379

Start Date:

March 2012

Completion Date:

March 2016

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer
  • Radiation
  • Chemotherapy
  • Surgery
  • Dynamic contrast enhanced computed tomography
  • Head and Neck Neoplasms

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