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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
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Papillary Thyroid Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 16, 2017
    Last Updated
    November 30, 2017
    Sponsor
    University Health Network, Toronto
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    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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