The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

Differentiated Thyroid Cancer Clinical Trial

— DTC  

Official title:

A Phase II Study of the Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04447183
• Other study ID #: ZGTSH002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 23, 2020
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.

Description:

This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). 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 Thyrogen (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. All patients received the same amount of radioactive iodine (30mCi±1.5mCi or 1.11GBq of 131I). Approximately 9 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;

• Patients who were at 18~75 years old (male or female).

• Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)?) thyroid remnant ablation.

• Serum TSH = 0.5 mU/L;

• Women of childbearing age are HCG-negative;

• Low iodine diet before enrollment for more than 4 weeks;

• Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program.

Exclusion Criteria:

• Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);

• Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration;

• Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);

• Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia;

• Pregnant or lactating women;

• Patients who are allergic to rhTSH and its excipients;

• Patients with positive infection-related tests : Includes hepatitis C?syphilis and AIDS;

• Participated in any drug or medical device clinical trial within 1 month prior to the trial.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)
rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

Other:
• radioactive iodine
radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablation success rate by Diagnostic Whole Body Scan (DxWBS)	In the THW state (TSH=30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.	at week 36
Secondary	Serum thyroglobulin (Tg) levels	In the THW state (TSH=30mU/L), the proportion of patients with Tg levels <1ng/mL and neck B-ultrasound negative during rhTSH stimulation accounted for all subjects.	at week 36
Secondary	Adverse Event	Classification and degree of adverse events	up to week 40 ± 7 day