Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06405217

Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-05-08

30

Participants Needed

1

Research Sites

140 weeks

Total Duration

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AI-Summary

What this Trial Is About

Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer . Experimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks. The two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (\>30mU/L). The efficacy and adverse reactions were observed.

CONDITIONS

Official Title

Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old (inclusive)
  • ECOG performance status of 0 to 2 points
  • Expected survival time over 3 months
  • Diagnosed with differentiated thyroid carcinoma after total or subtotal thyroidectomy
  • Confirmed locally recurrent or metastatic disease by imaging, serum tumor marker, or biopsy
  • At least one measurable tumor lesion of 10 mm or larger meeting RECIST 1.1 criteria
  • Hemoglobin level of at least 80 g/L
  • Neutrophil count of at least 1.5 x 10^9/L
  • Platelet count of at least 80 x 10^9/L
  • Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 60 ml/min
  • Blood urea nitrogen less than or equal to 2.5 times upper limit of normal
  • Total bilirubin less than or equal to 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal
  • If liver metastasis present, ALT and AST less than or equal to 5 times upper limit of normal
  • Albumin level at least 25 g/L
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment and agree to use reliable contraception during the trial and for 1 year after last 131I dose; men must agree to use contraception for 6 months after last 131I dose
  • Voluntary participation with signed informed consent and ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • Severe and uncontrolled diseases including:
    1. Uncontrolled hypertension with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite treatment
    2. Poorly controlled arrhythmias or ischemic heart disease with grade II or higher myocardial infarction, prolonged QT interval (male ≥450 ms, female ≥470 ms), or congestive heart failure (NYHA class ≥2)
    3. Poorly controlled diabetes with fasting blood sugar >10 mmol/L
    4. Active or poorly controlled severe infections (CTCAE grade ≥2)
    5. Active hepatitis B or C infection or infections requiring antimicrobial therapy
    6. Renal insufficiency with urine protein ≥++ or 24-hour urine protein ≥1.0 g
    7. Seizures requiring treatment
  • Surgical treatment, incisional biopsy, or major trauma within 28 days before randomization
  • History of or inability to stop psychiatric medication abuse
  • Allergy to recombinant human thyroid stimulating hormone, 131I, or their excipients
  • Infection within 4 weeks prior to screening with ongoing symptoms
  • Recent use of lipophilic iodine contrast agents within 3 months or water-soluble iodine contrast agents within 1 month prior to screening
  • Pregnant or lactating women, or women with unprotected sex within 2 weeks prior to screening or positive pregnancy test
  • Men or women planning fertility or donation during the study period and 6 months after, and unwilling to use contraception
  • Any condition deemed by researchers to harm the participant or prevent study compliance

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nanjing First Hospital

Nanjing, Jiangsu, China, 210006

Actively Recruiting

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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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