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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Chulalongkorn University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00984191
First received: September 24, 2009
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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 Intervention
Papillary Thyroid Cancer
Radiation: 99mTc-MIBI SPECT-CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy ) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 24, 2009
Last Updated: June 23, 2011
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on July 29, 2014