1. WELCOME!!! FDA & MITA RT Meeting
June 13, 2013

2. Agenda Overview (Joy M. Sacmar)
Planning of Radiotherapy Treatments (Mary Napolitano)
Inputs to Planning
Treatment Delivery (Rajinder Dhada)
ROSSI - Radiation Oncology Stakeholders’ Safety Initiative (Jim Schewe)
IHE-RO – Integrating Healthcare Enterprise – Radiation Oncology (Chris Pauer)
RT Manufacturer's Readiness Check Initiative (Jim Schewe)
Wrap-Up

3. Introduction
Radiation has been an effective tool for treating cancer for over 100 years
More than 60 percent of patients diagnosed with cancer will receive radiation therapy as part of their treatment
More than 1 million cancer patients are treated annually with radiation
Radiation oncologists are cancer specialists who manage cancer patients with radiation

4. Overview Physical and biological basis for radiation
Types of radiation available
Process for treatment
Imaging & Simulation
Treatment planning
Delivery of radiation
Radiation Treatment Safety

5. A Brief History of Radiation
Wilhelm Roentgen discovered X-rays on November 8, 1895
In 1896, Henri Becquerel discovered radioactivity
Pierre and Marie Curie announced the discovery of radium and polonium in 1898
These elements emitted ,  and  rays
Early radiograph taken by Roentgen, January, 1896.
Roentgen - while experimenting with a gas-filled cathode tube; he noted an image of the bones of his hand projected on a screen when placed between the tube and the fluorescent screen
Henri Becquerel discovered while experimenting with pitchblende (i.e., uranium salts) and a shrouded photographic plate
Image of Becquerel’s photographic plate fogged by exposure to radiation from uranium salts.

6. X-rays and Gamma Radiation
Both are forms of ionizing radiation
X-rays and -rays are collectively referred to as photons and are considered a form of electromagnetic radiation
Energy is produced when an accelerated electron strikes a target, decelerates and emits X-rays
Gamma-radiation occurs when an unstable nucleus gives off excess energy in the form of -rays as it decays to a more stable form

7. Radiotherapy at the Cellular Level
Radiation used for cancer treatment is called ionizing radiation because it forms ions as it passes through tissues and dislodges electrons from atoms
Molecular damage may occur through direct or indirect ionization
DNA is the most important target molecule
An image of cancer cells.

8. Effects of Ionizing Radiation
Ionization within cells results in physical, chemical and biological changes
Damage to DNA molecule by formation of free radicals
The net result on cancer cells is an inability to grow and subsequently reproduce

9. Sources of Ionizing Radiation
Electromagnetic Waves
Gamma Rays
Emitted from a radioactive source
Cobalt treatment machine
X-rays
Photons are generated by a linear accelerator
Particle Beams
Protons
Neutrons
Electrons
Most external beam radiation treatments use photons generated by a linear accelerator.

10. A Basic Radiobiologic Principle
Fractionation, or dividing the total dose into small daily fractions over several weeks, produces better tumor control than a single large fraction
Fractionation spares normal tissue through repair and repopulation while increasing damage to tumor cells through redistribution and reoxygenation

11. Process of Care: Initial Steps
Patients are referred for consultation
After a tissue diagnosis has been established
Radiation Treatment s recommended by the radiation oncologist
Simulation is carried out
Provides a blueprint for treatment
Usually done as a treatment planning CT scan
Patient set up in the treatment position
Immobilization may be used to ensure daily reproducibility

12. Process of Care: Radiation Treatment Planning
Sophisticated software is used to carefully derive an appropriate treatment plan for each patient
Computerized algorithms enable the treatment plan to spare as much healthy tissue as possible
Physicist and dosimetrist work together create the optimal treatment plan for each individual patient
Radiation oncologists work with medical physicists and dosimetrists to plan treatment to deliver a maximum dose of radiation to the tumor and avoid healthy tissue.

13. Process of Care: Delivery of Radiation Therapy
Radiation therapy can be delivered two ways
External beam radiation therapy typically delivers radiation using a linear accelerator
Internal radiation therapy, called brachytherapy, involves placing radioactive sources into or near the tumor
The type of treatment used will depend on the location, size and type of cancer.

14. Types of External Beam Radiation Therapy
Three-dimensional conformal radiation therapy (3D-CRT)
Intensity modulated radiation therapy (IMRT)
Image Guided Radiation Therapy (IGRT)
Nine-field IMRT head and neck 3-D schematic.

15. Stereotactic Full-Body Radiotherapy
High doses of radiation are delivered using tiny fields over one to five days
Very thin beams of radiation focused at small tumors
When used in a single treatment for tumors in the head, it is called stereotactic radiosurgery (SRS)
When used in multiple treatments or for other parts of the body, it’s called stereotactic body radiation therapy (SBRT)

16. Is Radiation Therapy Safe?
Radiation has been safely used on cancer for more than a century.
Many advances have been made to ensure it remains safe and effective.
The treatment plan is constantly checked and updated to ensure proper treatment is being given.
Equipment is routinely examined to make sure it is only giving the dose of radiation prescribed. .
Patients who receive external radiation are not radioactive. Healthcare workers only need to take special precaution when treating patients receiving some types of brachytherapy.

17. Manufacturer’s Commitment to Safety
IEC Standards Specific to RT e.g.
Particular requirements for safety – Specification for electron accelerators in the range 1MeV to 50MeV
62083 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
60976/60977 Medical electrical equipment – Medical electron accelerators – Functional performance characteristics
Extensive Testing
Design QA - Verification and Validation Testing
Production-Manufacturing QA
Installation QA – Acceptance Testing
Involvement with on-going Safety Initiatives
ROSSI
IHE-RO
Acknowledgement: Material from this presentation was obtained from ASTRO