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Tests treatment safety and results for Recombinant Human Thyroid Stimulating Hormone
Official title Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
ClinicalTrials.gov ID: NCT06431620
What this study is testing
What is Recombinant Human Thyroid Stimulating Hormone?
Recombinant Human Thyroid Stimulating Hormone is an investigational medicine, given as an once-daily injection into a muscle, being studied as a potential treatment for recombinant human thyroid stimulating hormone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18\~75 years old (including 18 and 75 years old);
- ECOG: 0-2 points;
- Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as...
- Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min...
- Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to...
You likely can't join if
- Accompanied by pleural effusion or ascites, causing respiratory distress;
- Symptoms of brain metastasis cannot be controlled and treated in less than 2 months; there is a risk of suffocation due to excessively large neck...
- Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure...
- Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;
- Unable to quit or with a history of psychiatric medication abuse;
- Allergic to the investigational drug (rhTSH or 131I) or its excipients;
See the full eligibility criteria
- Age: 18\~75 years old (including 18 and 75 years old);
- ECOG: 0-2 points;
- Expected survival of more than 3 months; Differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker...
- Hemoglobin ≥80g/L, neutrophil ≥1.5×109/L, platelet count ≥80×109/L, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, Blood urea nitrogen ≤2.5× upper limit of normal (ULN); Total bilirubin...
- Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate...
- Participants voluntarily joined the study and signed informed consent, with good compliance and follow-up;
- Patients diagnosed with iodine-refractory/potentially iodine-refractory DTC after multidisciplinary team discussion.
- Accompanied by pleural effusion or ascites, causing respiratory distress;
- Symptoms of brain metastasis cannot be controlled and treated in less than 2 months; there is a risk of suffocation due to excessively large neck metastatic masses; patients with spinal bone metastases have a risk of...
- Patients with severe and uncontrolled diseases, including: 1) Uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); 2) Poorly controlled...
- Received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization;
- Unable to quit or with a history of psychiatric medication abuse;
- Allergic to the investigational drug (rhTSH or 131I) or its excipients;
- Had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening;
- Received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the...
- Pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening;
- Male people (or their partners) or female people who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt...
- Researchers believe that the presence of any condition may harm the people or prevent them from meeting or fulfilling the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.