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

History of Changes

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:

MedlinePlus related topics: Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid

Genetic and Rare Diseases Information Center resources: Papillary Thyroid Carcinoma

U.S. FDA Resources

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 Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms	Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Diseases

ClinicalTrials.gov processed this record on February 27, 2015

To Top