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Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid

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ClinicalTrials.gov Identifier: NCT00984191
Recruitment Status : Unknown
Verified June 2011 by Chulalongkorn University.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Chulalongkorn University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Papillary Thyroid Cancer Radiation: 99mTc-MIBI SPECT-CT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study
Study Start Date : March 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 99mTc positive
99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report
 Radiation: 99mTc-MIBI SPECT-CT
99mTc-MIBI SPECT-CT for abnormal cervical lymph node
Experimental: 99mTc Negative_Neck dissection
99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report
 Radiation: 99mTc-MIBI SPECT-CT
99mTc-MIBI SPECT-CT for abnormal cervical lymph node
Experimental: 99mTc Negative_No neck dissection
99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan
 Radiation: 99mTc-MIBI SPECT-CT
99mTc-MIBI SPECT-CT for abnormal cervical lymph node


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy ) [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984191


Locations
Thailand
King Chulalongkorn Hospital
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Napadon Tangjaturonrasme, Otolaryngologist Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
More Information
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Responsible Party: Napadon Tangjaturonrasme, Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00984191     History of Changes
Other Study ID Numbers: NapadonChula_01
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Chulalongkorn University:
Papillary thyroid cancer
99mTechnetium MIBI SPECT CT
preoperative
cervical lymphadenopathy
cervical metastasis

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type