ThyroidectomyNCT03349294
Clinical Study of Biokinetic Model of Iodine-131 in Total(Near) Thyroidectomy Patients.
An observational study of Thyroidectomy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Thyroid cancer patients who have undergone total thyroidectomy, postoperative iodine 131 treatment to ablation residual thyroid tissue, is the current clinical practice. The effective half-life of the iodine 131 in the human body and in vivo exposure dose can be assessed by the in vivo kinetic model published by ICRP… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroidectomy
- How many people
- 11 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2017to 31 Dec 2019
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion with gastrointestinal surgery.
Who may be able to join
- All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Thyroid cancer patients who have undergone total thyroidectomy, postoperative iodine 131 treatment to ablation residual thyroid tissue, is the current clinical practice. The effective half-life of the iodine 131 in the human body and in vivo exposure dose can be assessed by the in vivo kinetic model published by ICRP, but this model is based on standard healthy people and can not be corrected for patients undergoing total thyroidectomy.
In this study, the investigators will use the actual clinical data to revise the biokinetic model of iodine-131 in patients with total thyroidectomy.
Read the detailed description
Methods Patients:All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion with gastrointestinal surgery.
Preparation:The patient of this study, their medication and diet and other matters needing attention, are in accordance with the original to accept iodine -131 30mCi treatment of the standard treatment.
Imaging Protocol:After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively. Image collection will use GE Infinia Hawkeye 4 SPECT / CT with high energy general purpose collimator. The imaging parameters use the original I-131 whole body scan protocol.
Expected results:Image data is further analyzed by MATLAB software to obtain iodine 131 in the body of individual organs of the biological half-life and path strength percentage. This analysis can revise the iodine -131 biokinetic model of patients with total thyroidectomy, providing more accurate calculations and subsequent studies.
- Conditions
- Thyroidectomy
- Keywords
- Thyroid, Thyroidectomy, Iodine, Biokinetic, Ablation
- Medical subject headings
- Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The I-131 distributed among the internal organs after the dose administration can be thoroughly analyzed according to a revised MATLAB program.
Image data is further analyzed by MATLAB software
Measured: After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Nov 2017
- Primary completion31 Aug 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao-Chun Huang, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349294
- Sponsor's protocol ID
- 106132-F
- Status last verified
- Nov 2017
- First submitted
- 20 Oct 2017
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Biokinetic Model of Iodine-131 in Total(Near) Thyroidectomy Patients.
- ClinicalTrials.gov ID
- NCT03349294
- Acronym / sponsor ID
- 106132-F
- Conditions
- Thyroidectomy
- Keywords
- Thyroid, Thyroidectomy, Iodine, Biokinetic, Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Nov 2017 (actual)
- 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.
Thyroid cancer patients who have undergone total thyroidectomy, postoperative iodine 131 treatment to ablation residual thyroid tissue, is the current clinical practice. The effective half-life of the iodine 131 in the human body and in vivo exposure dose can be assessed by the in vivo kinetic model published by ICRP, but this model is based on standard healthy people and can not be corrected for patients undergoing total thyroidectomy.
In this study, the investigators will use the actual clinical data to revise the biokinetic model of iodine-131 in patients with total thyroidectomy.
Detailed description
Methods Patients:All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion with gastrointestinal surgery.
Preparation:The patient of this study, their medication and diet and other matters needing attention, are in accordance with the original to accept iodine -131 30mCi treatment of the standard treatment.
Imaging Protocol:After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively. Image collection will use GE Infinia Hawkeye 4 SPECT / CT with high energy general purpose collimator. The imaging parameters use the original I-131 whole body scan protocol.
Expected results:Image data is further analyzed by MATLAB software to obtain iodine 131 in the body of individual organs of the biological half-life and path strength percentage. This analysis can revise the iodine -131 biokinetic model of patients with total thyroidectomy, providing more accurate calculations and subsequent studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion with gastrointestinal surgery.
Key inclusion criteria (1 listed)
- All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The I-131 distributed among the internal organs after the dose administration can be thoroughly analyzed according to a revised MATLAB program.
Time frame: After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively.
Image data is further analyzed by MATLAB software
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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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.
Chao-Chun Huang principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroidectomy, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 0 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: finished, as of the sponsor's last update on 23 Feb 2022. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The I-131 distributed among the internal organs after the dose administration can be thoroughly analyzed according to a revised MATLAB program. (time frame: After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively.). 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 23 Feb 2022.