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

Primary Purpose

Differentiated Thyroid Cancer

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)

radioactive iodine

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)Ⅰ) 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.

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Test group

Control group

Arm Description

The test 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 control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Adverse Event

Classification and degree of adverse events

Full Information

NCT ID

NCT04447183

First Posted

June 23, 2020

Last Updated

October 20, 2023

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04447183

Brief Title

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

Acronym

DTC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 23, 2020 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Differentiated Thyroid Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

A randomized, open, parallel controlled, multi-center clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Experimental

Arm Description

The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.

Intervention Type

Drug

Intervention Name(s)

Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)

Other Intervention Name(s)

radioactive iodine

Intervention Description

rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

Intervention Type

Other

Intervention Name(s)

radioactive iodine

Intervention Description

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

Primary Outcome Measure Information:

Title

Ablation success rate by Diagnostic Whole Body Scan (DxWBS)

Description

In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.

Time Frame

at week 36

Secondary Outcome Measure Information:

Title

Serum thyroglobulin (Tg) levels

Description

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.

Time Frame

at week 36

Title

Adverse Event

Description

Classification and degree of adverse events

Time Frame

up to week 40 ± 7 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)Ⅰ) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yansong Lin, PhD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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