Actively Recruiting
Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced or Metastatic Differentiated Thyroid Cancer
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-05-08
30
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of recombinant human thyroid stimulating hormone (TSH) injection compared to traditional thyroid hormone withdrawal in patients with postoperative local recurrent or metastatic differentiated thyroid cancer. This study aims to observe how well these treatments elevate plasma TSH levels and monitor any adverse reactions following radioiodine 131I treatment. The study is sponsored by Nanjing First Hospital, Nanjing Medical University. Participants are randomly assigned to one of two groups. The experimental group receives an intramuscular injection of recombinant human TSH at a dose of 0.9 mg once daily for two consecutive days. The control group undergoes thyroid hormone withdrawal for 4 to 6 weeks to elevate TSH levels naturally. After TSH levels exceed 30 mU/L, both groups receive radioiodine 131I therapy. Researchers compare the rate of TSH elevation and the incidence of treatment-emergent adverse events between these two approaches. During the study, participants are closely monitored with assessments of TSH levels 24 hours after the second recombinant human TSH injection or 4 to 6 weeks after thyroid hormone withdrawal in the control group. They are also followed for treatment-related adverse events up to three months after therapy completion and overall response rates at 4 months. The total age range for participants is 18 to 75 years, and comprehensive health evaluations are conducted to ensure safety and adherence.
CONDITIONS
Brief Title
Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old (inclusive)
- ECOG performance status of 0 to 2 points
- Expected survival longer than 3 months
- Diagnosed with differentiated thyroid carcinoma after total or subtotal thyroidectomy with confirmed local recurrence or metastasis
- At least one measurable tumor lesion with diameter of 10 mm or more meeting RECIST 1.1 criteria
- Adequate blood counts and organ function within specified limits
- Women of childbearing potential must have negative pregnancy test within 7 days prior to enrollment and agree to reliable contraception during and after the study
- Voluntary participation with informed consent and ability to comply with study requirements
You will not qualify if you...
- Severe uncontrolled diseases such as uncontrolled hypertension, significant heart conditions, poorly controlled diabetes, severe infections, active hepatitis B or C, renal insufficiency with proteinuria, or seizures requiring treatment
- Recent surgery, biopsy, or major trauma within 28 days before randomization
- History of psychiatric medication abuse or inability to quit
- Allergic to recombinant human thyroid stimulating hormone, 131I, or any excipients
- Recent infection within 4 weeks prior to screening
- Recent use of iodine contrast agents within specified timeframes before screening
- Pregnant or lactating women, or women with recent unprotected sexual intercourse or positive pregnancy test
- Plans for fertility or donation of sperm or ova during study and unwillingness to use contraception
- Any condition that may harm the participant or prevent study participation according to researchers' judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 6 weeks
Participants receive either recombinant human thyroid stimulating hormone injections once daily for two days or undergo thyroid hormone withdrawal for 4 to 6 weeks before radioiodine treatment.
1 to 2 visits depending on treatment group
Duration - Up to 3 months
Participants are monitored for treatment-emergent adverse events and overall response for up to 3 months after completion of therapy.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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