Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer
1 other identifier
interventional
10
1 country
2
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedStudy Start
First participant enrolled
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 11, 2021
May 1, 2021
1.7 years
May 6, 2021
May 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month
Study Arms (1)
124I PET/CT
EXPERIMENTALAll eligible patients will be allocated to this arm (single-arm study).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients underwent total thyroidectomy.
- Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.
- Distant metastases confirmed by CT etc.
You may not qualify if:
- Pregnancy or lactation.
- Significant hepatic or renal dysfunction;
- Unable to lie flat, still or tolerate a PET scan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Cancer Hospital
Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 11, 2021
Study Start
May 6, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
May 11, 2021
Record last verified: 2021-05