Papillary Thyroid CancerPhase 4MHINCT07354698
Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery
A Phase 4 study testing mitoxantrone hydrochloride injection in people with Papillary Thyroid Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Dear Patient, You are invited to participate in a clinical study investigating the Application of Mitoxantrone Hydrochloride Injection for Lymphatic Tracing in Transoral Robotic Thyroid Cancer Surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- mitoxantrone hydrochloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, both male and female;
- Preoperative neck ultrasound and/or puncture pathology suggested thyroid cancer, and postoperative pathology diagnosed thyroid cancer (tumor diameter <4cm);
- There are no obvious contraindications to surgery during routine preoperative examination;
- Meet the indications for thyroid lobe/total resection + unilateral/bilateral central lymph node dissection;
- Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up. 4.2 Exclusion Criteria
Who cannot join
- Those who have a history of severe drug allergy or are allergic to the drugs in this study;
- Those with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematological system;
- Combined with parathyroid disease or other calcium and phosphorus metabolism-related diseases;
- Benign thyroid lesions;
- Received mitoxantrone treatment within 4 weeks;
- Enrolled in other clinical studies at the same time;
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- Known history of psychotropic drug abuse, alcohol abuse or drug abuse;
- Pregnant or lactating women;
- According to the investigator's judgment, the subject has other factors that may cause him to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory examination values, family or social factors, which may affect the safety of the subject or the collection of trial data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Daping Hospital
Chongqicun, 400042
Fu Luo, 15121528940, luofu@tmmu.edu.cn
Yan Xu, 15923100038, luofu@tmmu.edu.cn
About this study
Dear Patient, You are invited to participate in a clinical study investigating the Application of Mitoxantrone Hydrochloride Injection for Lymphatic Tracing in Transoral Robotic Thyroid Cancer Surgery. This protocol (Protocol No.: [To be filled]) has been reviewed and approved by the Ethics Committee of the Army Center of Specialized Medicine.
- Background and Objectives 1.1 Disease Burden and Current Treatments 1.1.1 Thyroid Cancer Surgery Thyroid cancer, the most common head and neck malignancy, exhibits rising global incidence. Central compartment lymph nodes are frequent sites of metastasis in papillary thyroid carcinoma (PTC). Transoral endoscopic thyroid surgery offers superior cosmesis versus open surgery. The da Vinci® robotic system enhances visualization and instrument maneuverability, overcoming technical limitations of narrow endoscopic operating channels.
Read more
1.1.2 Lymphatic Tracers in Thyroid Surgery
Mitoxantrone Hydrochloride Injection for Lymphatic Tracing is China's only approved tracer for thyroid lymphatic mapping. Its high lymphotropic specificity enables:
Lymph node mapping: Forms nanocrystals that permeate lymphatics, staining nodes blue.
Parathyroid negative imaging: Spares parathyroid glands, aiding their identification and reducing postoperative hypocalcemia.
1.2 Study Objectives
Primary: Compare lymph node dissection efficacy and parathyroid protection between:
Intervention: Transoral robotic thyroid lobectomy/total thyroidectomy + central neck dissection (CND) with lymphatic tracing.
Control: Identical surgery without tracing.
Secondary:
- Compare postoperative parathyroid function between groups.
- Evaluate tracer sensitivity for metastatic lymph nodes.
1.3 Participating Site and Sample Size Site: Army Center of Specialized Medicine Sample: 114 treatment-naïve PTC patients scheduled for transoral robotic surgery (Jan-Dec 2024).
Intervention group (n=57): Mitoxantrone Hydrochloride tracing Control group (n=57): No tracer II. Study Procedures Pre-study: Medical history review, preoperative assessments, and documentation of concomitant medications (30 days postsurgery).
Intervention:
Thyroid exposure → Intervention group: Multisite intraglandular tracer injection (0.1 mL/site, depth ≈0.3 cm; total dose thyroid-dependent).
Both groups: Thyroid lobectomy/total thyroidectomy ± unilateral/bilateral CND. Intraoperative recording: Thyroid characteristics, tracer dose/injection sites, lymphadenectomy duration.
Pathology:
Total lymph node yield and blue-staining rate. Intraoperative frozen section + final histopathology for metastatic nodes.
Follow-up (Postoperative Day 7±3):
Physical exam, vital signs, lab tests (CBC, biochemistry, thyroid/parathyroid hormones, electrolytes).
12-lead ECG. Safety monitoring: Adverse events (AEs) tracked until Postoperative Day 14. III. Potential Benefits Improved lymphatic mapping → Reduced parathyroid injury, enhanced lymph node clearance, lower AE rates.
Tracer provided at no cost by the sponsor. Note: Efficacy is not guaranteed. Alternative treatments exist. IV. Risks and Inconveniences Potential AEs: Per product labeling and surgical risks. Procedural burdens: Multiple hospital visits and tests. AE management: Immediate medical intervention provided. Compensation per GCP regulations if injury is trial-related.
- Costs Tracer: NMPA-approved and insurance-covered. Routine care/medications: Patient/insurance responsibility. AE compensation: Sponsor-covered if causally related (per Chinese GCP). VI. Confidentiality
Medical records accessible only to:
Research team Ethics Committee Regulatory authorities No personally identifiable data will be published. VII. Contact Information Ethics Committee: 68757140 Principal Investigator: Dr. Yan Xu / TEL: 68729250 VIII. Voluntary Participation Right to withdraw anytime without penalty. Investigator may discontinue your participation for safety/administrative reasons.
Exit assessments may be required. IX. Decision Process Discuss with your physician/family. Retain this document.
Participant Signature: ___________________ Date: _________
Investigator Signature: ___________________ Date: _________
Read the detailed description
- Incidence of hypoparathyroidism
- Positive lymph node tracing rate
- Conditions
- Papillary Thyroid Cancer
- Being tested
- mitoxantrone hydrochloride injection
- Keywords
- Mitoxantrone Hydrochloride Injection, Transoral Robotic Surgery
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitoxantrone hydrochloride injectionDrug
The experimental group used mitoxantrone hydrochloride injection as a lymphatic tracer to distinguish the parathyroid glands and lymph nodes according to the blue staining during the operation.
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Injection | Experimental | The experimental group used mitoxantrone hydrochloride injection as a lymphatic tracer to distinguish the parathyroid glands and lymph nodes according to the blue staining during the operation. Receives: Drug: mitoxantrone hydrochloride injection |
| the blank control group | No intervention | the blank control group does not receive any tracers, and the operating surgeon distinguishes the parathyroid glands and lymph nodes with the naked eye with experience, anatomy, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of parathyroid missections
Number of parathyroid missections
Measured: 1week
Secondary outcomes (1)
Number of lymph node dissections in the central region
Number of lymph node dissections in the central region
Measured: 2week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354698
- Sponsor's protocol ID
- No.08[2024]
- Other IDs
- No.08[2024]
- Acronym
- MHI
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is confidential and the study data is not open to the public
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery
- ClinicalTrials.gov ID
- NCT07354698
- Acronym / sponsor ID
- MHI / No.08[2024]
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Mitoxantrone Hydrochloride Injection, Transoral Robotic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dear Patient, You are invited to participate in a clinical study investigating the Application of Mitoxantrone Hydrochloride Injection for Lymphatic Tracing in Transoral Robotic Thyroid Cancer Surgery. This protocol (Protocol No.: [To be filled]) has been reviewed and approved by the Ethics Committee of the Army Center of Specialized Medicine.
- Background and Objectives 1.1 Disease Burden and Current Treatments 1.1.1 Thyroid Cancer Surgery Thyroid cancer, the most common head and neck malignancy, exhibits rising global incidence. Central compartment lymph nodes are frequent sites of metastasis in papillary thyroid carcinoma (PTC). Transoral endoscopic thyroid surgery offers superior cosmesis versus open surgery. The da Vinci® robotic system enhances visualization and instrument maneuverability, overcoming technical limitations of narrow endoscopic operating channels.
1.1.2 Lymphatic Tracers in Thyroid Surgery
Mitoxantrone Hydrochloride Injection for Lymphatic Tracing is China's only approved tracer for thyroid lymphatic mapping. Its high lymphotropic specificity enables:
Lymph node mapping: Forms nanocrystals that permeate lymphatics, staining nodes blue.
Parathyroid negative imaging: Spares parathyroid glands, aiding their identification and reducing postoperative hypocalcemia.
1.2 Study Objectives
Primary: Compare lymph node dissection efficacy and parathyroid protection between:
Intervention: Transoral robotic thyroid lobectomy/total thyroidectomy + central neck dissection (CND) with lymphatic tracing.
Control: Identical surgery without tracing.
Secondary:
- Compare postoperative parathyroid function between groups.
- Evaluate tracer sensitivity for metastatic lymph nodes.
1.3 Participating Site and Sample Size Site: Army Center of Specialized Medicine Sample: 114 treatment-naïve PTC patients scheduled for transoral robotic surgery (Jan-Dec 2024).
Intervention group (n=57): Mitoxantrone Hydrochloride tracing Control group (n=57): No tracer II. Study Procedures Pre-study: Medical history review, preoperative assessments, and documentation of concomitant medications (30 days postsurgery).
Intervention:
Thyroid exposure → Intervention group: Multisite intraglandular tracer injection (0.1 mL/site, depth ≈0.3 cm; total dose thyroid-dependent).
Both groups: Thyroid lobectomy/total thyroidectomy ± unilateral/bilateral CND. Intraoperative recording: Thyroid characteristics, tracer dose/injection sites, lymphadenectomy duration.
Pathology:
Total lymph node yield and blue-staining rate. Intraoperative frozen section + final histopathology for metastatic nodes.
Follow-up (Postoperative Day 7±3):
Physical exam, vital signs, lab tests (CBC, biochemistry, thyroid/parathyroid hormones, electrolytes).
12-lead ECG. Safety monitoring: Adverse events (AEs) tracked until Postoperative Day 14. III. Potential Benefits Improved lymphatic mapping → Reduced parathyroid injury, enhanced lymph node clearance, lower AE rates.
Tracer provided at no cost by the sponsor. Note: Efficacy is not guaranteed. Alternative treatments exist. IV. Risks and Inconveniences Potential AEs: Per product labeling and surgical risks. Procedural burdens: Multiple hospital visits and tests. AE management: Immediate medical intervention provided. Compensation per GCP regulations if injury is trial-related.
- Costs Tracer: NMPA-approved and insurance-covered. Routine care/medications: Patient/insurance responsibility. AE compensation: Sponsor-covered if causally related (per Chinese GCP). VI. Confidentiality
Medical records accessible only to:
Research team Ethics Committee Regulatory authorities No personally identifiable data will be published. VII. Contact Information Ethics Committee: 68757140 Principal Investigator: Dr. Yan Xu / TEL: 68729250 VIII. Voluntary Participation Right to withdraw anytime without penalty. Investigator may discontinue your participation for safety/administrative reasons.
Exit assessments may be required. IX. Decision Process Discuss with your physician/family. Retain this document.
Participant Signature: ___________________ Date: _________
Investigator Signature: ___________________ Date: _________
Detailed description
- Incidence of hypoparathyroidism
- Positive lymph node tracing rate
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Injection | Experimental | Drug: mitoxantrone hydrochloride injectionThe experimental group used mitoxantrone hydrochloride injection as a lymphatic tracer to distinguish the parathyroid glands and lymph nodes according to the blue staining during the operation. |
| the blank control group | No intervention | –the blank control group does not receive any tracers, and the operating surgeon distinguishes the parathyroid glands and lymph nodes with the naked eye with experience, anatomy, etc. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years old, both male and female;
- Preoperative neck ultrasound and/or puncture pathology suggested thyroid cancer, and postoperative pathology diagnosed thyroid cancer (tumor diameter <4cm);
- There are no obvious contraindications to surgery during routine preoperative examination;
- Meet the indications for thyroid lobe/total resection + unilateral/bilateral central lymph node dissection;
- Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up. 4.2 Exclusion Criteria
Key exclusion criteria (9 listed)
- Those who have a history of severe drug allergy or are allergic to the drugs in this study;
- Those with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematological system;
- Combined with parathyroid disease or other calcium and phosphorus metabolism-related diseases;
- Benign thyroid lesions;
- Received mitoxantrone treatment within 4 weeks;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitoxantrone hydrochloride injectionThe experimental group used mitoxantrone hydrochloride injection as a lymphatic tracer to distinguish the parathyroid glands and lymph nodes according to the blue staining during the operation. | Drug | Mitoxantrone Hydrochloride Injection |
Primary outcome
Number of parathyroid missections
Time frame: 1week
Number of parathyroid missections
1 secondary outcome
Number of lymph node dissections in the central region
Time frame: 2week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. The study is confidential and the study data is not open to the public
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mitoxantrone hydrochloride injection in people with Papillary Thyroid Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xu, PhD (15923100038, xy931@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of parathyroid missections (time frame: 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.