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

NCT ID: NCT04880798

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Differentiated Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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124I PET/CT

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

Group Type EXPERIMENTAL

124I PET/CT

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yansong Lin

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yansong Lin, Prof

Role: CONTACT

86-010-69155610

Zhi Yang, Prof

Role: CONTACT

86-010-88196196

Facility Contacts

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Yan-Song Lin

Role: primary

Role: backup

8601069155610

Zhi Yang, Prof

Role: primary

86-010-88196196

Other Identifiers

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PUMCH-BCH-124I

Identifier Type: -

Identifier Source: org_study_id

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