CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer

November 30, 2017 updated by: University Health Network, Toronto
Localized thyroid cancer is potentially curable. Before thyroid surgery, an ultrasound test is done to see if cancer has spread to the lymph nodes in the neck. Excellent for evaluation of the thyroid gland, this test has limitations in evaluating larger anatomic areas, like all groups of lymph nodes in the neck. It has a limited area of coverage making it difficult to define an area of interest, depends on the skill level of the person performing it, and is difficult to exactly reproduce on follow-up. For these reasons, CT is often performed in these patients but without intravenous (IV) contrast since iodine-based contrast agents may saturate the thyroid, limiting the usefulness of other iodine-based diagnostic and treatment options. However, contrast-CT can give more detailed information about tumor spread including spread to lymph nodes. We aim to determine if use of IV contrast agent during CT leads to earlier and more accurate detection of lymph node disease from thyroid cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Papillary thyroid cancer represents 75% of all epithelial thyroid malignancies. Imaging not only delineates the primary tumour within the thyroid gland, but also helps assess lymph nodal metastatic disease helping guide the extent of surgical neck dissection. Ultrasonography (US) is the current imaging standard (American Thyroid Association guidelines). However, US is limited by operator skills and lacks specific anatomic references essential to plan surgery. CT is performed to address these issues, often without intravenous (IV) contrast for fear of saturating thyroid tissue with iodine present in it, thus rendering iodine-labeled nuclear testing/treatment ineffective for a finite period of time. But post-contrast nodal enhancement is a predominant morphologic feature of suspicious lymphadenopathy in papillary thyroid cancer, and contrast-CT can facilitate an earlier detection. Iodine-saturation is not a concern in these patients as its concentration will normalize during recovery.

In pre-surgical thyroidectomy patients with proven papillary thyroid cancer, the use of intravenous (IV) CT contrast improves the reliability and accuracy of suspicious head and neck lymph node detection, in comparison to CT without IV contrast.

This study will help define the accuracy and reliability of intravenous (IV) contrast use in the detection of metastatic neck lymph nodes from papillary thyroid cancer. Improved detection of suspicious metastatic lymphadenopathy in papillary thyroid cancer will directly impact the patient's management since the surgical plan will be based upon the detection of these suspicious lymph nodes. CT imaging provides an anatomically relevant approach to surgery and is consistently reproducible, thus providing direct benefits to the pre-surgical assessment. Ultimately, this will result in decreased nodal recurrences within the neck.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pre-operative thyroidectomy patients with pathology-proven papillary thyroid cancer (PTC) needing lymph node staging for potential neck dissection.

Exclusion Criteria:

  • Patients with history of prior surgery within the head and neck.
  • Patients with history of prior radiation to the head and neck.
  • Patients with history of lymphoma, leukemia, or other lymphoproliferative disorders affecting the head and neck.
  • Pregnant/breast feeding patients (by question).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Non-contrast-enhanced CT
Comparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes
Diagnostic test: Use of IV contrast during head and neck CT
Use of IV contrast during head and neck CT
Other Names:
  • Non-contrast-enhanced CT of the head and neck
ACTIVE_COMPARATOR: Contrast-enhanced CT
Comparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes
Diagnostic test: Use of IV contrast during head and neck CT
Use of IV contrast during head and neck CT
Other Names:
  • Non-contrast-enhanced CT of the head and neck

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT
Time Frame: up to 7 years
up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 28, 2011

Primary Completion (ACTUAL)

April 20, 2017

Study Completion (ACTUAL)

April 20, 2017

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (ACTUAL)

December 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0192-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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