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

May 6, 2021 updated by: Yansong Lin, Peking Union Medical College Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhi Yang, Prof
  • Phone Number: 86-010-88196196
  • Email: pekyz@163.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Zhi Yang, Prof
          • Phone Number: 86-010-88196196
          • Email: pekyz@163.com
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Yan-Song Lin
        • Contact:
          • Phone Number: 8601069155610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-BCH-124I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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