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

Differentiated Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880798
• Other study ID #: PUMCH-BCH-124I
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Peking Union Medical College Hospital
• Contact: Yansong Lin, Prof
• Phone: 86-010-69155610
• Email: linyansong1968[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients underwent total thyroidectomy.

2. Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.

3. Distant metastases confirmed by CT etc.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Significant hepatic or renal dysfunction;

3. Unable to lie flat, still or tolerate a PET scan.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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