Heavy Ion Technology Unveils the Prelude to Research and Treatment of Benign Diseases as Knee Osteoa

Heavy Ion Technology Unveils the Prelude to Research and Treatment of Benign Diseases as Knee Osteoarthritis

Ultra-low-dose heavy ion therapy for intractable benign diseases like knee osteoarthritis has commenced clinical research and treatment at Gansu Wuwei Cancer Hospital. The costs of heavy ion therapy are covered by the research project funds, with zero out-of-pocket expenses for patients.

Osteoarthritis (OA) is a chronic degenerative joint disease and the most common type of arthritis, capable of affecting almost any joint in the body. It is a significant cause of chronic pain and disability in the elderly. Currently, research institutions abroad, represented by Germany, have conducted research and clinical practice involving tens of thousands of cases of radiotherapy for osteoarthritis. However, heavy ion therapy for osteoarthritis remains an unexplored area internationally.

Relying on the Gansu Provincial Chief Scientist Project "Research on Heavy Ion Therapy Technology for Non-Tumor Diseases," and with the support of a research team led by the Institute of Modern Physics, Chinese Academy of Sciences, Gansu Wuwei Cancer Hospital and related research teams officially initiated research on heavy ion therapy for knee osteoarthritis this year. This research focuses on overcoming the limitations of traditional treatment methods, striving to provide innovative "Chinese solutions" for patients with intractable knee osteoarthritis. Additionally, the conduct of this research will promote the expansion of heavy ion medicine into non-oncological treatment fields and is expected to bring new treatment options and rehabilitation hope to knee osteoarthritis patients worldwide.

Volunteer Inclusion Criteria

• Voluntarily participate in clinical research, fully understand and comprehend the study content, and sign the informed consent form, taking the crucial step to support medical progress of their own volitionity.
• Age requirement: females ≥50 years old, males ≥55 years old, aligning with the high-prevalence age group characteristics of the disease.
• Precisely meet the diagnostic criteria with reference to the 2018 guidelines for the diagnosis and treatment of knee osteoarthritis recommended by the Orthopaedic Branch of the Chinese Medical Association, ensuring the accuracy of the study subjects
• Imaging examinations (X-ray, CT, MRI, or others) definitively confirm the presence of imaging pathological changes of knee osteoarthritis, providing intuitive evidence for the research.
• Fasting blood glucose <6.1 mmol/L, and postprandial blood glucose between 6.1 mmol/L and 11.1 mmol/L, ensuring suitable basic metabolic indicators for participation in the trial.

The above conditions are the main criteria for judgment; final enrollment is determined by the investigator based on the trial protocol.

Volunteer Exclusion Criteria

• If there is a past medical history or current presence of severe insufficiency in organ functions such as heart, lung, liver, or kidney, making it difficult for the body to withstand the trial, temporary exclusion.
• Patients with traumatic arthritis, rheumatoid arthritis, and other similar conditions are not within the scope of this recruitment due to differences in pathogenesis and research direction.
• Those allergic to radiotherapy or with contraindications are not suitable to participate to ensure safety.
• Suffering from other infectious diseases that may interfere with the research results, leading to exclusion.
• Currently participating in other clinical research, or having just completed radiotherapy less than 30 days ago, to avoid the superimposed effects of multiple treatment factors; temporary exclusion.

Trial Design

1. Strictly adhere to the principles of clinical trial volunteer recruitment, fully respect patients' personal treatment wishes, and subdivide enrolled volunteers into non-radiation group, photon low-dose irradiation group, and heavy ion low-dose irradiation group. Utilizing the hospital's advanced heavy ion accelerator and linear accelerator equipment, patients will receive placebo therapy and low-dose irradiation interventions respectively.
2. Conduct a comprehensive series of tasks during key periods before and after low-dose radiotherapy, including imaging pathology evaluation of the knee joint, collection of joint effusion samples, blood sample collection, pain assessment, functional assessment, safety assessment, adverse event assessment, and efficacy assessment. Through rigorous before-and-after comparative analysis, precisely observe the clinical effects of low-dose radiotherapy.
3. The screening evaluation before the first treatment is crucial. After prospective patients sign the informed consent form (ICF), the screening process begins immediately, involving detailed collection and recording of disease-related information and arranging comprehensive examinations. The investigator will rigorously determine whether the patient meets the inclusion and exclusion criteria based on the latest examination results.
4. After the treatment concludes, the follow-up period begins immediately. Starting from the end of the last research treatment, all subjects will enter a 1-year safety follow-up period. During this time, regular safety assessments and adverse event tracking will be conducted at set time points: before treatment, and at 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months, and 1 year after the start of treatment. Simultaneously, comprehensively collect all adverse events potentially related to the research treatment from the signing of the ICF until 30 days after the last treatment (including the 30th day), and conduct scientific assessments based on incidence and severity.

Patient Rights and Benefits

1. The hospital provides research funds to the expert team to cover the heavy ion treatment costs for patients.
2. A multidisciplinary expert team (MDT) develops personalized plans throughout the entire process.
3. Receive regular follow-up monitoring for up to 3 years after treatment and priority access to new therapies.

Contact Information
Su Anping: 13893592413
Yang Qianzi: 15379332290
Ma Haitao: 17793510936
Xu Jianping: 18740983170
Wang Haiqing: 15193560091
Lv Quan: 19039511357
Yin Lirong: 17339942775