Differentiated Thyroid CancerNCT04880798
Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer
A study testing 124I PET/CT in people with Differentiated Thyroid Cancer, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
Distant metastases is the leading cause of differentiated thyroid cancer-related death. Radioactive iodine (RAI) treatment is the most effective therapy for RAI-avid metastatic differentiated thyroid cancer (DTC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- 124I PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 6 May 2021to 31 Dec 2022
- 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
- Patients underwent total thyroidectomy.
- Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.
- Distant metastases confirmed by CT etc.
Who cannot join
- Pregnancy or lactation.
- Significant hepatic or renal dysfunction;
- Unable to lie flat, still or tolerate a PET scan.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan-Song Lin
8601069155610
- Recruiting
Beijing Cancer Hospital
Beijing
Zhi Yang, Prof, 86-010-88196196, pekyz@163.com
About this study
Official title: Effect of Thyrotropin Level on Iodine Uptake: a Prospective 124I PET/CT Study in Metastatic Differentiated Thyroid Cancer
Distant metastases is the leading cause of differentiated thyroid cancer-related death. Radioactive iodine (RAI) treatment is the most effective therapy for RAI-avid metastatic differentiated thyroid cancer (DTC). It is well known that the efficacy of RAI therapy is depend on the sodium-iodide symporter protein, which can be synthesized by elevated thyrotropin stimulation. Therefore, thyrotropin stimulation before RAI treatment to ensure sufficient uptake of RAI has been a long-established procedure. According to some observational studies, thyrotropin of 25-30 μIU/mL has been adopted as the standard care protocol. However, whether thyrotropin of 25-30 μIU/mL is enough to stimulate iodine uptake in metastatic lesions remains unknown. In this study, the investigators aim to address the effect of thyrotropin on iodine uptake in metastatic DTC during levothyroxine withdrawal by two times 124I PET/CT scans on different endogenous thyrotropin levels.
Read the detailed description
It is estimated that 10 patients who met the study criteria will be enrolled. All patients underwent twice 124I PET/CT scans in Beijing Cancer Hospital. The first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, the second 124I PET/CT was prepared with endogenous thyrotropin >100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans.
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- 124I PET/CT
- Keywords
- differentiated thyroid cancer, pulmonary metastases, bone metastases, thyrotropin, thyroid stimulating hormone, 124I PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I PET/CTDiagnostic test
The first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, and the second 124I PET/CT was prepared with endogenous thyrotropin >100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans.
| Study group | Role | What they receive |
|---|---|---|
| 124I PET/CT | Experimental | All eligible patients will be allocated to this arm (single-arm study). Receives: Diagnostic Test: 124I PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of thyrotropin level on iodine uptake in metastatic DTC lesions on twice 124I PET/CT.
SUV metrics of RAI-avid metastatic DTC lesions on twice 124I PET/CT.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start6 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Yansong Lin, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880798
- Sponsor's protocol ID
- PUMCH-BCH-124I
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 11 May 2021
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thyrotropin Level on Iodine Uptake: a Prospective 124I PET/CT Study in Metastatic Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04880798
- Acronym / sponsor ID
- PUMCH-BCH-124I
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- differentiated thyroid cancer, pulmonary metastases, bone metastases, thyrotropin, thyroid stimulating hormone, 124I PET/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 May 2021 (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.
Distant metastases is the leading cause of differentiated thyroid cancer-related death. Radioactive iodine (RAI) treatment is the most effective therapy for RAI-avid metastatic differentiated thyroid cancer (DTC). It is well known that the efficacy of RAI therapy is depend on the sodium-iodide symporter protein, which can be synthesized by elevated thyrotropin stimulation. Therefore, thyrotropin stimulation before RAI treatment to ensure sufficient uptake of RAI has been a long-established procedure. According to some observational studies, thyrotropin of 25-30 μIU/mL has been adopted as the standard care protocol. However, whether thyrotropin of 25-30 μIU/mL is enough to stimulate iodine uptake in metastatic lesions remains unknown. In this study, the investigators aim to address the effect of thyrotropin on iodine uptake in metastatic DTC during levothyroxine withdrawal by two times 124I PET/CT scans on different endogenous thyrotropin levels.
Detailed description
It is estimated that 10 patients who met the study criteria will be enrolled. All patients underwent twice 124I PET/CT scans in Beijing Cancer Hospital. The first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, the second 124I PET/CT was prepared with endogenous thyrotropin >100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 124I PET/CT | Experimental | Diagnostic Test: 124I PET/CTAll eligible patients will be allocated to this arm (single-arm study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients underwent total thyroidectomy.
- Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.
- Distant metastases confirmed by CT etc.
Key exclusion criteria (3 listed)
- Pregnancy or lactation.
- Significant hepatic or renal dysfunction;
- Unable to lie flat, still or tolerate a PET scan.
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 |
|---|---|---|
| 124I PET/CTThe first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, and the second 124I PET/CT was prepared with endogenous thyrotropin >100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans. | Diagnostic test | 124I PET/CT |
Primary outcome
Effect of thyrotropin level on iodine uptake in metastatic DTC lesions on twice 124I PET/CT.
Time frame: 1 month
SUV metrics of RAI-avid metastatic DTC lesions on twice 124I PET/CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 124I PET/CT in people with Differentiated Thyroid Cancer, run by Peking Union Medical College Hospital at 2 sites in China.
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 3 inclusion and 3 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Contact Yansong Lin, Prof (86-010-69155610, linyansong1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of thyrotropin level on iodine uptake in metastatic DTC lesions on twice 124I PET/CT. (time frame: 1 month). 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 11 May 2021.