Differentiated Thyroid Cancer
Conditions
Brief summary
This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.
Interventions
BIOLOGICALrhTSH
rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH
RADIATIONRadioiodine (131I)
Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects voluntarily sign the informed consent form (ICF). * Age ≥ 18 years old, either male or female. * Patients with diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as pT 1-3, N 0-1or Nx, and M0. * Eastern Cooperative Oncology Group (ECOG) score of 0-2; * Expected life expectancy is greater than 12 weeks; * Patients with a total or near-total thyroidectomy within 12 months prior to randomized. * Low iodine diet for two weeks prior to randomized.
Exclusion criteria
* patients with recent history of 131I whole body scan within 2 weeks prior to randomized. * Pregnant or breast feeding women. * patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission) * Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator. * Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 months before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of successful postoperative thyroid ablation | 8 months later by a rhTSH stimulated radioiodine scan | Patients were considered successfully ablated if there was no visible thyroid bed uptake on the scan |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYansong Lin, PhD
Peking Union Medical College Hospital
Outcome results
None listed