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

Overview

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.

Full Title of Study: “99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Interventions

  • Radiation: 99mTc-MIBI SPECT-CT
    • 99mTc-MIBI SPECT-CT for abnormal cervical lymph node

Arms, Groups and Cohorts

  • Experimental: 99mTc positive
    • 99mTechnetium-MIBI SPECT-CT positive compare : Scan – Pathologic report
  • Experimental: 99mTc Negative_Neck dissection
    • 99mTc Negative but have neck dissection indication compare : 99mTc – Pathologic report
  • Experimental: 99mTc Negative_No neck dissection
    • 99mTc Negative and No other indication for neck dissection compare : 99mTc – 7. 131I (post-treatment) whole body scan

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
    • Time Frame: 18 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chulalongkorn University
  • Provider of Information About this Clinical Study
    • Napadon Tangjaturonrasme, Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
  • Overall Official(s)
    • Napadon Tangjaturonrasme, Otolaryngologist, Principal Investigator, Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University

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