Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04880798

Collaborator

Peking University Cancer Hospital & Institute (Other)

Enrollment

Locations

Arm

19.8

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Differentiated Thyroid Cancer	Diagnostic Test: 124I PET/CT	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Effect of Thyrotropin Level on Iodine Uptake: a Prospective 124I PET/CT Study in Metastatic Differentiated Thyroid Cancer

Actual Study Start Date :

May 6, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 124I PET/CT All eligible patients will be allocated to this arm (single-arm study).	Diagnostic Test: 124I PET/CT 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.

Arm

Intervention/Treatment

Experimental: 124I PET/CT

All eligible patients will be allocated to this arm (single-arm study).

Diagnostic Test: 124I PET/CT

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.

Outcome Measures

Primary Outcome Measures

Effect of thyrotropin level on iodine uptake in metastatic DTC lesions on twice 124I PET/CT. [1 month]
SUV metrics of RAI-avid metastatic DTC lesions on twice 124I PET/CT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients underwent total thyroidectomy.
Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.
Distant metastases confirmed by CT etc.