Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid
Primary Purpose
Papillary Thyroid Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
99mTc-MIBI SPECT-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Papillary Thyroid Cancer focused on measuring Papillary thyroid cancer, 99mTechnetium MIBI SPECT CT, preoperative, cervical lymphadenopathy, cervical metastasis
Eligibility Criteria
Inclusion Criteria:
- papillary thyroid cancer
Exclusion Criteria:
- pregnancy
- Bleeding abnormality
- Prior history of head and neck cancer
- can not perform 99mTechnetium-MIBI SPECT-CT
- can not perform 131I remnant Ablation
- Prior any head and neck surgery within 3 months
- Prior deep neck infection within 3 months
Sites / Locations
- King Chulalongkorn Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
99mTc positive
99mTc Negative_Neck dissection
99mTc Negative_No neck dissection
Arm Description
99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report
99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report
99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan
Outcomes
Primary Outcome Measures
Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
Secondary Outcome Measures
Full Information
NCT ID
NCT00984191
First Posted
September 24, 2009
Last Updated
June 23, 2011
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT00984191
Brief Title
Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid
Official Title
99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for preoperative evaluation of cervical node metastasis in papillary thyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Cancer
Keywords
Papillary thyroid cancer, 99mTechnetium MIBI SPECT CT, preoperative, cervical lymphadenopathy, cervical metastasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
99mTc positive
Arm Type
Experimental
Arm Description
99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report
Arm Title
99mTc Negative_Neck dissection
Arm Type
Experimental
Arm Description
99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report
Arm Title
99mTc Negative_No neck dissection
Arm Type
Experimental
Arm Description
99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan
Intervention Type
Radiation
Intervention Name(s)
99mTc-MIBI SPECT-CT
Intervention Description
99mTc-MIBI SPECT-CT for abnormal cervical lymph node
Primary Outcome Measure Information:
Title
Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
papillary thyroid cancer
Exclusion Criteria:
pregnancy
Bleeding abnormality
Prior history of head and neck cancer
can not perform 99mTechnetium-MIBI SPECT-CT
can not perform 131I remnant Ablation
Prior any head and neck surgery within 3 months
Prior deep neck infection within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Napadon Tangjaturonrasme, Otolaryngologist
Organizational Affiliation
Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Hospital
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid
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