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NCT00984191 Clinical Trial

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

Papillary Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00984191
Other study ID # NapadonChula_01
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 24, 2009
Last updated June 23, 2011
Start date March 2010
Est. completion date November 2011

Study information
Verified date June 2011
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date November 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Thailand King Chulalongkorn Hospital Pathumwan Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy ) 18 months No
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