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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549379

Enrollment

Registered

2012-03-09

Start date

2013-07-31

Completion date

2014-08-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer, Radiation, Chemotherapy, Surgery, Dynamic contrast enhanced computed tomography

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.

Interventions

RADIATIONDynamic 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of DCE-CT in predicting the presence of residual lymph node disease after the completion of chemotherapy	8-10 weeks post treatment

Secondary

Measure	Time frame
Sensitivity and specificity of DCE-CT in predicting presence of lymph node disease at surgery	Approximately 2-6 weeks after enrollment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026