- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00984191
Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid
June 23, 2011 updated by: Chulalongkorn University
99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Pathumwan, Bangkok, Thailand, 10330
- King Chulalongkorn Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 99mTc positive
99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report
|
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
|
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
|
99mTc-MIBI SPECT-CT for abnormal cervical lymph node
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Napadon Tangjaturonrasme, Otolaryngologist, Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
November 1, 2011
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
September 24, 2009
First Posted (Estimate)
September 25, 2009
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NapadonChula_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Papillary Thyroid Cancer
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage II Papillary Thyroid Cancer | Stage III Papillary Thyroid Cancer | Stage I Papillary Thyroid CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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University Health Network, TorontoUniversity of British Columbia; Canadian Institutes of Health Research (CIHR); CHU de Quebec-Universite Laval and other collaboratorsRecruitingPapillary Thyroid Carcinoma | Papillary Thyroid Cancer | Papillary Microcarcinoma of the ThyroidCanada
-
National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
Mayo ClinicActive, not recruitingPapillary Thyroid Cancer | Papillary Thyroid MicrocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
Grupo Espanol de Tumores NeuroendocrinosMFARActive, not recruitingMetastatic Thyroid Cancer | Metastatic Thyroid Papillary Carcinoma | Metastatic Thyroid Follicular CarcinomaSpain
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Massachusetts General HospitalCompletedPapillary Carcinoma of Thyroid Gland | Metastatic Medullary Thyroid Cancer | Follicular Thyroid Cancer Lymph Node MetastasisUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
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Emory UniversityRecruiting
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Peking Union Medical College HospitalNot yet recruitingIntracranial Tumor
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Tomsk National Research Medical Center of the Russian...Uppsala UniversityCompletedBreast Cancer FemaleRussian Federation
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