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

Primary Purpose

Differentiated Thyroid Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
124I PET/CT
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Differentiated Thyroid Cancer focused on measuring differentiated thyroid cancer, pulmonary metastases, bone metastases, thyrotropin, thyroid stimulating hormone, 124I PET/CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

124I PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2021
Last Updated
May 6, 2021
Sponsor
Peking Union Medical College Hospital
Collaborators
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04880798
Brief Title
Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer
Official Title
Effect of Thyrotropin Level on Iodine Uptake: a Prospective 124I PET/CT Study in Metastatic Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer
Keywords
differentiated thyroid cancer, pulmonary metastases, bone metastases, thyrotropin, thyroid stimulating hormone, 124I PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
124I PET/CT
Arm Type
Experimental
Arm Description
All eligible patients will be allocated to this arm (single-arm study).
Intervention Type
Diagnostic Test
Intervention Name(s)
124I PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of thyrotropin level on iodine uptake in metastatic DTC lesions on twice 124I PET/CT.
Description
SUV metrics of RAI-avid metastatic DTC lesions on twice 124I PET/CT.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients underwent total thyroidectomy. Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination. Distant metastases confirmed by CT etc. Exclusion Criteria: Pregnancy or lactation. Significant hepatic or renal dysfunction; Unable to lie flat, still or tolerate a PET scan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yansong Lin, Prof
Phone
86-010-69155610
Email
linyansong1968@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, Prof
Phone
86-010-88196196
Email
pekyz@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan-Song Lin
Phone
8601069155610
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Yang, Prof
Phone
86-010-88196196
Email
pekyz@163.com

12. IPD Sharing Statement

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

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