CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer

NCT03359668 | Completed DMC

• 1 other identifier: 11-0192-C
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT

  up to 7 years

Study Arms (2)

Non-contrast-enhanced CT

EXPERIMENTAL

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

Contrast-enhanced CT

ACTIVE COMPARATOR

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

Interventions

Use of IV contrast during head and neck CT DIAGNOSTIC_TEST

Use of IV contrast during head and neck CT

Also known as: Non-contrast-enhanced CT of the head and neck

Contrast-enhanced CT; Non-contrast-enhanced CT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will read the randomized non-contrast CTs separately from the contrast-enhanced CTs
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient had CT imaging with and without IV contrast

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 2, 2017
• Study Start: April 28, 2011
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share