Actively Recruiting
Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-05-28
15
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, inclusive
- ECOG performance status between 0 and 2
- Expected survival longer than 3 months
- Diagnosed differentiated thyroid carcinoma with total or subtotal thyroidectomy
- Confirmed locally recurrent or metastatic disease by imaging, tumor marker, or biopsy
- At least one measurable tumor lesion 10 mm or larger meeting RECIST 1.1 criteria
- Hemoglobin level at least 80 g/L
- Neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 80 x 10^9/L
- Serum creatinine at or below 1.5 times the upper limit of normal or creatinine clearance at least 60 ml/min
- Blood urea nitrogen at or below 2.5 times the upper limit of normal
- Total bilirubin at or below 1.5 times the upper limit of normal
- AST and ALT at or below 2.5 times the upper limit of normal; if liver metastasis present, ALT and AST at or below 5 times the upper limit of normal
- Albumin level at least 25 g/L
- Women of childbearing potential must use reliable contraception or have a negative pregnancy test within 7 days prior to enrollment
- Willingness to use contraception during the trial and for 1 year after last radioactive iodine dose (women) or 6 months after last dose (men)
- Voluntary participation with informed consent and good compliance
- Diagnosed iodine-refractory or potentially iodine-refractory differentiated thyroid cancer after multidisciplinary review
You will not qualify if you...
- Presence of pleural effusion or ascites causing breathing difficulty
- Uncontrolled brain metastasis symptoms or risk of suffocation from large neck tumors
- Spinal bone metastases posing risk of spinal cord compression paralysis
- Cardiac metastasis, heart failure, or risk of acute cardiovascular events
- Severe uncontrolled diseases including uncontrolled hypertension, serious arrhythmias, congestive heart failure (NYHA class 2 or above), poorly controlled diabetes, active severe infections, active hepatitis B or C infection, significant proteinuria, or seizure disorders requiring treatment
- Surgery, incisional biopsy, or major trauma within 28 days prior to randomization
- History of psychiatric medication abuse or inability to stop medications
- Allergy to rhTSH, radioactive iodine (131I), or related substances
- Infection within 4 weeks prior to screening with ongoing symptoms
- Recent use of lipophilic or water-soluble iodine contrast agents within specified time frames
- Pregnancy, lactation, unprotected sexual intercourse within 2 weeks before screening, or positive pregnancy test
- Plans for fertility or sperm/egg donation during the study or unwillingness to use contraception during and up to 6 months after the study
- Any condition judged by researchers to pose risk or interfere with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical Univerity
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
F
Feng Wang
CONTACT
L
Liang Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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