OP40 – Mitoxantrone hydrochloride as a novel lymphatic tracer in thyroid surgery: a phase I clinical trial

     

    Chen, Shaobo1; Chen, Ge2; Wang, Junru3; Sun, Jian4; Zhao, Wenjing1;
    1 Department of Surgery, Peking Union Medical College Hospital, Beijing, China
    2 Department of General Surgery, Peking Union Medical College Hospital, Beijing, China
    3 Department of Pharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, China
    4 Department of Pathology, Peking Union Medical College Hospital, Beijing, China

     

    Background: Parathyroid gland injury is a common post-operative complication following thyroid surgery. We developed a novel lymphatic tracer from mitoxantrone hydrochloride, a widely-used chemotherapeutic agent, that could be helpful in visualizing and preserving parathyroid glands during surgery. In animal studies, a small amount of mitoxantrone hydrochloride is injected into the thyroid gland. Surrounding lymphatic tissues are turned into dark-purple color while the parathyroid gland is left unstained, thus helping the surgeon to better localize and preserve them.

    Methods: Patients with thyroid nodules suspected for malignancy were enrolled and planned for surgery. Written consents were signed with all patients. Mitoxantrone hydrochloride was injected directly into the thyroid gland during surgery. Thyroidectomy and lymph node dissections were carried out as planned while the parathyroid glands were carefully dissected and preserved. Blood samples were collected after drug injection to measure possible blood concentration. Pathological studies were routinely carried out. All patients were followed up for possible adverse drug effects and post-operative complications.

    Results: 15 patients were selected for the study (3 for control with no drug injection). Lymphatic tissues near the thyroid gland turned black in less 1-3 minute. All parathyroid glands were visualized and preserved in situ. 2 patients developed paresthesia in post-operative day 1 and symptoms resolved with vitamin-D and calcium supplementation within 2 weeks. Blood concentrations of mitroxantrone were undetectable in all patients. No drug-related adverse effects were observed.

    Conclusion: Mitoxantrone hydrochloride is a safe lymphatic tracer that could help preserving parathyroid glands during thyroidectomy.

 

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