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A single-center, randomized, open, blank parallel controlled clinical study on the efficacy and safety of Mitoxantrone Hydrochloride Injection for Tracing in patients with thyroid cancer undergoing different surgeries

A single-center, randomized, open, blank parallel controlled clinical study on the efficacy and safety of Mitoxantrone Hydrochloride Injection for Tracing in patients with thyroid cancer undergoing different surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073612
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-07-17
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thyroid cancer

Interventions

Conventional open surgery + tracer group :Mitoxantrone Hydrochloride Injection for Tracing was used
TOETVA + tracer group:Mitoxantrone Hydrochloride Injection for Tracing was used
Conventional open surgery + tracer group :NONE
TOETVA + no tracer group:NONE

Sponsors

Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age of 18-70 years old (including 18 and 70 years old), male and female 2. Preoperative clinical diagnosis of thyroid cancer, planned to undergo radical resection of thyroid cancer 3. According to preoperative evaluation, thyroid lobe/total resection + cervical lymph node dissection was planned 4. No obvious surgical contraindications were found in routine preoperative examination 5. Able to communicate well with researchers and complete research according to research regulations 6. Patients voluntarily participated in this study and signed informed consent. Note: The standard of "lobectomy/total thyroidectomy + neck lymph node dissection" referred to the 2015 American Thyroid Association Management Guidelines for Adult Patientswith Thyroid Nodules and Differentiated Thyroid Cancer

Exclusion criteria

Exclusion criteria: 1. Hypersensitive constitution, or a history of severe drug allergy, or allergic to anthraquinones 2. A history of drug abuse in the past 1 year 3. Patients with a history of thyroid surgery, thyroid isotope therapy or neck radiotherapy 4. Hemoglobin (HB) 3 times the upper limit of normal (ALT and AST in patients with liver metastases > 5 times the upper limit of normal) 6. Serum creatinine (Cr) > 1.5 times upper limit of normal (ULN) 7. Participants who participated in other clinical trials within 3 months before the trial 8. Patients with neurological disease, mental illness or intellectual disability who cannot correctly describe their feelings 9. Pregnant and lactating women 10. The subjects and their spouses plan to conceive during the trial and within 6 months after the trial 11. The research personnel of the trial are not allowed to participate in the study as subjects. 12. In addition to the above, subjects judged by the investigator to be unfit to participate.

Design outcomes

Primary

MeasureTime frame
Lymph tracing rate;The rate of improper parathyroidectomy;Lymphatic staining rate;The rate of parathyroid misstaining;

Secondary

MeasureTime frame
Total number of lymph nodes removed;The total number of metastatic lymph nodes removed;The removed lymph nodes were graded and counted;

Countries

China

Contacts

Public Contactxiaowei peng

Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University.

pengxiaowei@hnca.org.cn+86 187 7405 5986

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026