RecruitingNot ApplicableNCT06431620

Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

15 participants

Start Date

Jun 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Exogenous injection of recombinant human thyroid stimulating hormone (rhTSH) can elevate TSH in the short term (2 days) to meet the requirements of diagnostic 131I SPECT/CT whole-body scans. Antiangiogenic tyrosine kinase inhibitors (TKI) couuld alter the uptake of radioactive 131I in locally advanced or metastatic differentiated thyroid cancer. rhTSH can help to perform the diagnostic 131I SPECT/CT whole-body scans before and after the TKI usage. rhTSH can reduce the risk of tumor progression caused by thyroid hormone withdrawal period and the side effects of hypothyroidism also caused by thyroid hormone withdrawal, and clarify the 131I uptake change after TKI treatment.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a lab-made version of a hormone (recombinant human TSH) to help doctors better detect and monitor thyroid cancer that has come back or spread after surgery, without requiring patients to stop their thyroid medication. **You may be eligible if...** - You are between 18 and 75 years old - You have differentiated thyroid cancer (a common, treatable type) and had your thyroid fully or mostly removed - Imaging or lab tests show that your cancer has returned locally or spread elsewhere - You have at least one measurable tumor - Your blood counts, kidney, and liver function are within acceptable ranges - Your general health is reasonably good (ECOG score 0–2) - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You are allergic to the study drug - You have received certain other treatments recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Human Thyroid Stimulating Hormone

recombinant human thyrotropin (rhTSH) injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days.


Locations(1)

The First Affiliated Hospital of Nanjing Medical Univerity

Nanjing, Jiangsu, China

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NCT06431620