CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer
Primary Purpose
Papillary Thyroid Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of IV contrast during head and neck CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Papillary Thyroid Cancer
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-contrast-enhanced CT
Contrast-enhanced CT
Arm Description
Comparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes
Comparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes
Outcomes
Primary Outcome Measures
Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT
Secondary Outcome Measures
Full Information
NCT ID
NCT03359668
First Posted
November 16, 2017
Last Updated
November 30, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03359668
Brief Title
CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer
Official Title
CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 28, 2011 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each patient had CT imaging with and without IV contrast
Masking
Investigator
Masking Description
The investigator will read the randomized non-contrast CTs separately from the contrast-enhanced CTs
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-contrast-enhanced CT
Arm Type
Experimental
Arm Description
Comparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes
Arm Title
Contrast-enhanced CT
Arm Type
Active Comparator
Arm Description
Comparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes
Intervention Type
Diagnostic Test
Intervention Name(s)
Use of IV contrast during head and neck CT
Other Intervention Name(s)
Non-contrast-enhanced CT of the head and neck
Intervention Description
Use of IV contrast during head and neck CT
Primary Outcome Measure Information:
Title
Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT
Time Frame
up to 7 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer
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