Heavy Ion Technology Ushers in a New Era in the Treatment of Benign Diseases Like Knee Osteoarthriti

Heavy Ion Technology Ushers in New Era for Benign Disease Treatment: Pioneering Research on Knee Osteoarthritis

Clinical Research on Ultra-Low-Dose Heavy Ion Therapy for Refractory Benign Diseases including Knee Osteoarthritis Begins at Wuwei Cancer Hospital in Gansu Province. The treatment costs are covered by research funding, 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 nearly any joint in the body. It is a leading cause of chronic pain and disability in elderly populations. Currently, research institutions abroad, particularly in Germany, have conducted studies and clinical practices involving tens of thousands of cases of radiotherapy for osteoarthritis. However, heavy ion therapy for osteoarthritis remains an unexplored area internationally.  

Supported by the *Chief Scientist Project on Heavy Ion Therapy Technology for Non-Oncological Diseases* in Gansu Province and led by a research team organized by the Institute of Modern Physics, Chinese Academy of Sciences, Wuwei Cancer Hospital in Gansu Province, together with its research team, have officially initiated research on heavy ion therapy for knee osteoarthritis this year. This study focuses on overcoming the limitations of traditional treatment methods, aiming to provide an innovative "Chinese solution" for patients with refractory knee osteoarthritis. Additionally, the research will advance the application of heavy ion medicine in non-oncological fields, potentially offering new treatment options and hope for recovery to osteoarthritis patients worldwide.

Volunteer Inclusion Criteria

1. Voluntary Participation: Willingly join the clinical study, fully understand the research content, and sign an informed consent form, taking a crucial step toward advancing medical progress of their own accord.  

2. Age Requirement: Females ≥50 years old, males ≥55 years old, aligning with the high-risk age group for the disease.  

3. Diagnostic Confirmation: Strictly meet the diagnostic criteria for knee osteoarthritis as outlined in the 2018 guidelines recommended by the Chinese Orthopaedic Association, ensuring subject accuracy.  

4. Imaging Evidence: Definitive imaging findings (X-ray, CT, MRI, or others) confirming pathological changes of knee osteoarthritis, providing objective support for the study.  

5. Blood Glucose Levels: Fasting blood glucose <6.1 mmol/L, postprandial blood glucose between 6.1–11.1 mmol/L, ensuring baseline metabolic indicators are suitable for trial participation.  

The above criteria serve as primary screening standards. Final enrollment decisions will be made by researchers in accordance with the trial protocol.

Volunteer Exclusion Criteria

1. Severe Organ Dysfunction: Individuals with a history or current presence of severe cardiac, pulmonary, hepatic, renal, or other organ insufficiency that may compromise their ability to tolerate the trial will be excluded.

2. Non-Osteoarthritis Joint Diseases: Patients with traumatic arthritis, rheumatoid arthritis, or other similar conditions that differ in pathogenesis from knee osteoarthritis are not eligible for recruitment.

3. Radiotherapy Contraindications: Those with allergies or contraindications to radiotherapy will be excluded to ensure safety.  

4. Active Infectious Diseases: Individuals with other infectious diseases that may interfere with study outcomes will be excluded.  

5. Concurrent Clinical Trials or Recent Radiotherapy: Participation in other clinical studies or completion of radiotherapy within the past 30 days will be excluded to avoid overlapping treatment effects.

Trial Design

1. Strict Volunteer Recruitment and Grouping

  - Adhering strictly to clinical trial volunteer recruitment principles while fully respecting patients' treatment preferences, eligible volunteers will be stratified into three groups:  

   - Non-radiation group  

   - Low-dose photon irradiation group  

   - Low-dose heavy-ion irradiation group  

   - Utilizing the hospital's advanced heavy-ion accelerator and linear accelerator equipment, patients will receive either placebo treatment or low-dose irradiation interventions.  

2. Comprehensive Assessments Before and After Treatment  

  - Key evaluations will be conducted at critical time points before and after low-dose radiotherapy, including:  

    - Imaging-pathological assessment of the knee joint  

    - Synovial fluid sample collection  

    - Blood sample collection  

    - Pain and functional assessments  

    - Safety and efficacy evaluations  

    - Adverse event monitoring  

  - Rigorous comparative analysis will be performed to evaluate the clinical effectiveness of low-dose radiotherapy.  

3. Pre-Treatment Screening and Enrollment

  - Initial screening assessments are critical. After signing the informed consent form (ICF), prospective patients will undergo a detailed screening process, including comprehensive disease-related data collection and diagnostic tests.  

  - Based on the latest test results, researchers will rigorously determine whether the patient meets the inclusion/exclusion criteria.  

4. Follow-Up Protocol

  - After treatment completion, all participants will enter a **1-year safety follow-up period**, calculated from the last day of study treatment.  

  - Scheduled follow-ups will occur at:  

    - Baseline (pre-treatment)  

    - 3 weeks, 6 weeks, 9 weeks, and 12 weeks post-treatment  

    - 6 months and 1 year post-treatment  

  - All adverse events (AEs) potentially related to the study treatment—occurring from ICF signing until **30 days after the final treatment**—will be systematically recorded and evaluated based on incidence and severity.

Patient Rights & Benefits

1. Full Financial Coverage: Treatment costs for heavy ion therapy will be covered by research funding provided by the hospital to the expert team.

2. Personalized Treatment Plans: A multidisciplinary expert team (MDT) will develop tailored treatment strategies for each patient.

3. Long-Term Follow-Up: Participants will receive regular follow-up monitoring for up to 3 years post-treatment, with priority access to innovative therapies.

Contact Information

• Su Anping: +86 138-9359-2413
• Yang Qianzi: +86 153-7933-2290
• Li Zhiqiang: +86 138-9359-6550
• Ma Haitao: +86 177-9351-0936
• Su Yumei: +86 188-9450-6111
• Xu Jianping: +86 187-4098-3170
• Xu Degang: +86 150-9561-6633
• Qian Wenxu: +86 138-3054-0886
• Ma Weidong: +86 151-0137-1663
• Li Jinlong: +86 187-9353-6859
• Wang Jianqin: +86 153-7933-0063