Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer

Completed

Conditions studied: Papillary Thyroid Cancer

In brief

This research study is performed to compare the accuracy of two methods of lymph node evaluation: research method versus standard method. Standard method is what is usually performed as standard of care where the radiologist evaluates the images overall and decides whether each node seen should or should not be biopsied. In the research method, a second radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a small specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. Results of both the standard and research method will be used to decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node evaluation by standard method and subsequent lymph node biopsy are part of the standard clinical care. It is less likely but possible that the research method may identify additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.

Key facts

Study ID

NCT02442661

Run by

University of Colorado, Denver

People needed

103

Starts

2015-04-01

Expected to finish

2017-05-01

Last updated by the study team

2017-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PTC and at least one sonographic examination of the cervical lymph nodes.
• Patients can only be included in the study once. Thus, if they have two sonographic examinations, only one can be included in the study results.
• All patients who fit the study criteria after the start of the study will be included, using the first sonographic exam as the study exam.

You may not qualify if…

• Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar Doppler flow by ultrasound are considered to be normal and be excluded from FNAB per standard clinical practice.
• Lymph node less than 5 mm in short axis on ultrasound.

Where it is running

• Rebecca J Guigli — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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