Papillary Thyroid CancerNCT00984191
Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid
A study testing 99mTc-MIBI SPECT-CT in people with Papillary Thyroid Cancer, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- 99mTc-MIBI SPECT-CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- papillary thyroid cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- 99mTc-MIBI SPECT-CT
- Keywords
- Papillary thyroid cancer, 99mTechnetium MIBI SPECT CT, preoperative, cervical lymphadenopathy, cervical metastasis
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-MIBI SPECT-CTRadiation
99mTc-MIBI SPECT-CT for abnormal cervical lymph node
| Study group | Role | What they receive |
|---|---|---|
| 99mTc positive | Experimental | 99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report Receives: Radiation: 99mTc-MIBI SPECT-CT |
| 99mTc Negative_Neck dissection | Experimental | 99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report Receives: Radiation: 99mTc-MIBI SPECT-CT |
| 99mTc Negative_No neck dissection | Experimental | 99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan Receives: Radiation: 99mTc-MIBI SPECT-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionOct 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Napadon Tangjaturonrasme, Otolaryngologist, Principal investigator, Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984191
- Sponsor's protocol ID
- NapadonChula_01
- Status last verified
- Jun 2011
- First submitted
- 24 Sep 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTechnetium-MIBI SPECT-CT for Pre-operative Evaluation of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma; A Pilot Study
- ClinicalTrials.gov ID
- NCT00984191
- Acronym / sponsor ID
- NapadonChula_01
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Papillary thyroid cancer, 99mTechnetium MIBI SPECT CT, preoperative, cervical lymphadenopathy, cervical metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 99mTc positive | Experimental | Radiation: 99mTc-MIBI SPECT-CT99mTechnetium-MIBI SPECT-CT positive compare : Scan - Pathologic report |
| 99mTc Negative_Neck dissection | Experimental | Radiation: 99mTc-MIBI SPECT-CT99mTc Negative but have neck dissection indication compare : 99mTc - Pathologic report |
| 99mTc Negative_No neck dissection | Experimental | Radiation: 99mTc-MIBI SPECT-CT99mTc Negative and No other indication for neck dissection compare : 99mTc - 7. 131I (post-treatment) whole body scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- papillary thyroid cancer
Key exclusion criteria (7 listed)
- pregnancy
- Bleeding abnormality
- Prior history of head and neck cancer
- can not perform 99mTechnetium-MIBI SPECT-CT
- can not perform 131I remnant Ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-MIBI SPECT-CT99mTc-MIBI SPECT-CT for abnormal cervical lymph node | Radiation | 99mTc Negative_Neck dissection, 99mTc Negative_No neck dissection, 99mTc positive |
Primary outcome
Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy )
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Napadon Tangjaturonrasme, Otolaryngologist principal investigator
Department of Otolaryngology , Faculty of Medicine , Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-MIBI SPECT-CT in people with Papillary Thyroid Cancer, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Tool Statistic (PPV , NPV , Sensitivity , Specificity , Accuracy ) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.