Therapeutic radiopharmaceuticals play a major role in today's nuclear medicine with a positive impact on the diagnosis and treatment of diseases. One area of application is radiation synovectomy (RSV). Previously, RSV agents were often simple colloids. More recently, matrixes labelled with short/medium range beta emitters have been developed. However, the lack of generic and peer-reviewed production, quality control as well as clinical application guidelines and recommendations, are a major concern for their application in patients. This publication presents recommendations and suggestions for production, quality control and quality assurance procedures for Member State laboratories in charge of radiopharmaceutical production, with a focus on the latest RSV agents. It also proposes standard operating procedures for RSV application in patients. The publication aims to assist both newcomers and those currently working in the field in establishing comparable levels of control.

• 1. INTRODUCTION
  • 1.1. Background
  • 1.2. Objectives
  • 1.3. Scope
  • 1.4. Structure
• 2. RADIOSYNOVECTOMY IN THE TREATMENT OF SYNOVITIS
  • 2.1. Definition
  • 2.2. History
  • 2.3. Synovial joints
  • 2.4. Synovitis
  • 2.5. Rheumatoid arthritis
  • 2.6. Osteoarthritis
  • 2.7. Haemophilia
  • 2.8. Pigmented villonodular synovitis
• 3. PATIENT SELECTION FOR RADIOSYNOVECTOMY
  • 3.1. Mechanism of action
  • 3.2. Indications
  • 3.3. Patient preference
  • 3.4. Indication for repeating radiosynovectomy
  • 3.5. Contraindications
  • 3.6. Adverse effects of radiosynovectomy
• 4. Production of radionuclides required for RADIOSYNOVECTOMY
  • 4.1. Introduction
  • 4.2. Targeting
    • 4.2.1. 198Au
    • 4.2.2. 165Dy
    • 4.2.3. 169Er
    • 4.2.4. 166Ho
    • 4.2.5. 177Lu
    • 4.2.6. 32P
    • 4.2.7. 186Re
    • 4.2.8. 188Re
    • 4.2.9. 153Sm
    • 4.2.10. 117mSn
    • 4.2.11. 90Y
• 5. Radiopharmaceuticals for RADIOSYNOVECTOMY
  • 5.1. Principle
    • 5.1.1. Radionuclide selection
  • 5.2. Characteristics of radionuclides used in radiosynovectomy
  • 5.3. Particles for radionuclides
    • 5.3.1. Particle selection
    • 5.3.2. Particle size
    • 5.3.3. Common particles used in radiosynovectomy
  • 5.4. Key particles used in radiosynovectomy
    • 5.4.1. Glass
    • 5.4.2. Chitosan
    • 5.4.3. Silicate
    • 5.4.4. Citrate
    • 5.4.5. Polylactic acid
    • 5.4.6. Hydroxyapatite
    • 5.4.7. Hydro- and solvothermal
    • 5.4.8. Solid state reactions
    • 5.4.9. Sol-gel process
  • 5.5. Preparation of radioactive particles
    • 5.5.1. Radiolabelling during particle preparation
    • 5.5.2. Radiolabelled particles after their preparation
  • 5.6. Key radionuclides evaluated for synovectomy
    • 5.6.1. 198Au
    • 5.6.2. 165Dy
    • 5.6.3. 169Er
    • 5.6.4. 166Ho
    • 5.6.5. 177Lu
    • 5.6.6. 32P
    • 5.6.7. 186Re
    • 5.6.8. 188Re
    • 5.6.9. 153Sm
    • 5.6.10. 117mSn
    • 5.6.11. 90Y
• 6. Method used to prepare particles for RADIOSYNOVECTOMY
  • 6.1. Introduction
  • 6.2. Precipitation
  • 6.3. Emulsion: Evaporation or extraction of solvent
  • 6.4. Sol-gel process
  • 6.5. Spray drying
  • 6.6. Electrospraying
• 7. Regulatory and Manufacturing Issues
  • 7.1. Radiopharmaceutical manufacturing elements
    • 7.1.1. Personnel
    • 7.1.2. Premises and equipment
    • 7.1.3. Documentation
    • 7.1.4. Training
    • 7.1.5. Quality assurance
    • 7.1.6. Quality control
    • 7.1.7. Responsibilities
  • 7.2. Quality evaluation of radiosynovectomy agents
    • 7.2.1. Quality control of the particle
    • 7.2.2. Quality control of radionuclides
    • 7.2.3. Quality control of radiolabelled particles
  • 7.3. Documentation
    • 7.3.1. General requirements
    • 7.3.2. Preparation procedures
    • 7.3.3. Batch records
    • 7.3.4. Staff training
    • 7.3.5. Validation of training
    • 7.3.6. Retraining
    • 7.3.7. Periodic review of training
• 8. Standard operating procedure for RADIOSYNOVECTOMY
  • 8.1. Informed consent
  • 8.2. Diagnosis
  • 8.3. Facilities
  • 8.4. Preparation of patients
  • 8.5. Instrumentation
  • 8.6. Utensils
  • 8.7. Considerations for the receipt and handling of radiopharmaceuticals
  • 8.8. Puncture
  • 8.9. Post-radiosynovectomy procedures
  • 8.10. Post-radiosynovectomy imaging
  • 8.11. Follow-up
  • 8.12. Outcome
  • 8.13. Radiation protection
  • 8.14. Conclusion
• REFERENCES
• Annex I INFORMED CONSENT
• Annex II MEDICAL QUESTIONNAIRE
• ABBREVIATIONS
• CONTRIBUTORS TO DRAFTING AND REVIEW