Recombinant Human Thyroid Stimulating HormoneNCT06431620
Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Adjuvant Diagnosis in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer
A study testing Recombinant Human Thyroid Stimulating Hormone in people with Recombinant Human Thyroid Stimulating Hormone, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recombinant Human Thyroid Stimulating Hormone
- What is being tested?
- Recombinant Human Thyroid Stimulating Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (tg), biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.
- 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 ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L;
- 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 contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);
- 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.
Who cannot join
- 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 spinal cord compression paralysis; cardiac metastasis, heart failure, and patients at risk of acute cardiovascular events;
- 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 arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval (QTc) male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association (NYHA) classification); 3) Poorly controlled diabetes (fasting blood sugar \>10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus (HCV) RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.
- 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;
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- 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 past 1 month prior to screening;
- 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 subjects (or their partners) or female subjects 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 contraceptive measures during the study period and within 6 months after the end of the study;
- Researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical Univerity
Nanjing, Jiangsu, 210006
Feng Wang, 02552271455, fengwangcn@hotmail.com
Liang Shi, 02552271491, liangshi@njmu.edu.cn
About this study
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.
- Being tested
- Recombinant Human Thyroid Stimulating Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Thyroid Stimulating HormoneDrug
recombinant human thyrotropin (rhTSH) injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| rhTSH group | Experimental | rhTSH is used to raise blood TSH levels to meet the requirements of diagnostic 131I SPECT/CT whole-body scans before and after TKI medication. Receives: Drug: Recombinant Human Thyroid Stimulating Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSH
The proportion of patients with thyroid stimulating hormone>30 mIU/L
Measured: 24 hours after the second TSH injection
Secondary outcomes (1)
Positive diagnosis rate of lesions
Positive diagnosis rate of lesions in diagnostic 131I SPECT/CT whole-body scans
Measured: 72 hours after 131I treatment until progression or death, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recombinant Human Thyroid Stimulating HormoneStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Feng Wang, Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431620
- Sponsor's protocol ID
- KY20240514-03
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- KY20240514-03
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhTSH group | Experimental | Drug: Recombinant Human Thyroid Stimulating HormonerhTSH is used to raise blood TSH levels to meet the requirements of diagnostic 131I SPECT/CT whole-body scans before and after TKI medication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 (tg), biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of RECIST 1.1.
- 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 ≤1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST≤5×ULN albumin ≥25 g/L;
- 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 contraceptive methods during the trial and for 1 year after the last dose of 131I (for women), or for 6 months after the last dose of 131I (for men);
Key exclusion criteria (11 listed)
- 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 spinal cord compression paralysis; cardiac metastasis, heart failure, and patients at risk of acute cardiovascular events;
- 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 arrhythmias of ischemic heart disease or myocardial infarction of grade II or above (including corrected QT interval (QTc) male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (New York Heart Association (NYHA) classification); 3) Poorly controlled diabetes (fasting blood sugar \>10mmol/L); 4) Active or poorly controlled severe infections (according to Common Terminology Criteria for Adverse Events ≥ grade 2); 5) Patients with active hepatitis B or hepatitis C (hepatitis B: positive HBsAg and hepatitis B virus (HBV) DNA ≥500 IU/mL; hepatitis C: positive hepatitis C virus (HCV) RNA and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) Renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) Patients with seizures requiring treatment.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Thyroid Stimulating Hormonerecombinant human thyrotropin (rhTSH) injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. | Drug | rhTSH group |
Primary outcome
TSH
Time frame: 24 hours after the second TSH injection
The proportion of patients with thyroid stimulating hormone>30 mIU/L
1 secondary outcome
Positive diagnosis rate of lesions
Time frame: 72 hours after 131I treatment until progression or death, whichever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Wang principal investigator
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Human Thyroid Stimulating Hormone in people with Recombinant Human Thyroid Stimulating Hormone, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (02552271455, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSH (time frame: 24 hours after the second TSH injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.