Papillary Thyroid CancerNCT03359668
CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer
A study testing Use of IV contrast during head and neck CT in people with Papillary Thyroid Cancer, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- Use of IV contrast during head and neck CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2011to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-operative thyroidectomy patients with pathology-proven papillary thyroid cancer (PTC) needing lymph node staging for potential neck dissection.
Who cannot join
- 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).
About this study
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.
Read the 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.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- Use of IV contrast during head and neck CT
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of IV contrast during head and neck CTDiagnostic test
Also called Non-contrast-enhanced CT of the head and neck
Use of IV contrast during head and neck CT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Use of IV contrast during head and neck CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start28 Apr 2011
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient had CT imaging with and without IV contrast
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359668
- Sponsor's protocol ID
- 11-0192-C
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Detection of Metastatic Lymphadenopathy in Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT03359668
- Acronym / sponsor ID
- 11-0192-C
- Conditions
- Papillary Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 28 Apr 2011 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Each patient had CT imaging with and without IV contrast
| Arm | Type | Receives |
|---|---|---|
| Non-contrast-enhanced CT | Experimental | Diagnostic Test: Use of IV contrast during head and neck CTComparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes |
| Contrast-enhanced CT | Active comparator | Diagnostic Test: Use of IV contrast during head and neck CTComparison of non-contrast CT to the standard-of-care contrast-enhanced CT of the head and neck in detection of suspicious lymph nodes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pre-operative thyroidectomy patients with pathology-proven papillary thyroid cancer (PTC) needing lymph node staging for potential neck dissection.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of IV contrast during head and neck CTAlso: Non-contrast-enhanced CT of the head and neckUse of IV contrast during head and neck CT | Diagnostic test | Contrast-enhanced CT, Non-contrast-enhanced CT |
Primary outcome
Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT
Time frame: up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Cancer
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Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
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Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
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Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Use of IV contrast during head and neck CT in people with Papillary Thyroid Cancer, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased detection of suspicious lymph nodes in PTC with IV-contrast enhanced CT (time frame: up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.