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
Recruitment status was Active, not recruiting
Sponsor:
Chulalongkorn University
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00984191
First received: September 24, 2009
Last updated: June 23, 2011
Last verified: June 2011
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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 (Adult, Senior) |
| 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
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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
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
| 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:
|
Thyroid Diseases Thyroid Neoplasms Carcinoma Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on September 23, 2016