Guideline:
ACR practice guideline for the performance of low-dose-rate brachytherapy
Bibliographic Source(s)
- American College of Radiology (ACR). ACR practice guideline for the performance of low-dose-rate brachytherapy. Reston (VA): American College of Radiology (ACR); 2005. 5 p. [19 references]
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: American College of Radiology (ACR). ACR practice guideline for the performance of low-dose-rate brachytherapy. Reston (VA): American College of Radiology (ACR); 2000.
Guideline Category
Management
Treatment
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Nurses
Physician Assistants
Physicians
Guideline Objective(s)
- To assist practitioners in providing appropriate radiologic care for patients
- To describe principles of practice for low-dose-rate (LDR) brachytherapy in radiation oncology
Target Population
Patients undergoing low-dose-rate (LDR) brachytherapy
Note: This guideline does not apply to patients undergoing intravascular brachytherapy.
Interventions and Practices Considered
- Low-dose-rate (LDR) brachytherapy including
- Clinical evaluation
- Establishing treatment goals
- Obtaining informed consent
- Applicator/source insertion
- Treatment planning delivery and summary
- Safety considerations
- Patient evaluation during temporary implants
- Follow-up at regular intervals
- Qualifications of personnel
- Regular equipment inspection and maintenance
- Patient and personnel safety measures
- Continuing medical education for medical staff
- Documentation
Major Outcomes Considered
Not stated
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Not stated
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Each practice guideline and technical standard representing a policy statement by the American College of Radiology (ACR) has undergone a thorough consensus process in which it has been subjected to extensive review requiring the approval of the Commission on Quality and Safety as well as the ACR Board of Chancellors the ACR Council Steering Committee and the ACR Council.
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
The guidelines are approved by the Commission on Quality and Safety as well as the American College of Radiology (ACR) Board of Chancellors the ACR Council Steering Committee and the ACR Council.
Major Recommendations
Brachytherapy is the use of radioactive isotopes to treat malignancies or benign conditions by means of a radioactive source placed close to or into the tumor or treatment site. Brachytherapy alone or combined with external beam therapy plays an important role in the management and treatment of patients with cancer. Low-dose-rate (LDR) brachytherapy has traditionally been used as treatment for prostate head and neck breast cervical and endometrial cancers as well as obstructive esophageal or bronchial lesions. LDR brachytherapy has been used since the late 1800s with a variety of sources including radium-226 cesium-137 and more recently iridium-192 iodine-125 and palladium-103. Such treatment can be given as interstitial intracavitary or intraluminal therapy to a wide variety of treatment sites. This guideline does not apply to intravascular brachytherapy.
LDR brachytherapy is accomplished by 1) temporary implants after-loading radioactive sources into applicators that are placed into the patient or 2) permanent implants placing the isotope permanently into the cancerous tissue. Source handling can be manual with source loading into the applicator or tissue by hand or remote with source loading performed by a computerized unit. LDR brachytherapy is delivered at dose rates of 4 to 200 cGy per hour at a designated point.
The use of brachytherapy requires detailed attention to personnel equipment patient and personnel safety and continuing staff education. Since the practice of radiation oncology occurs in a variety of environments the judgment of the radiation oncologist and medical physicist should be used to apply these guidelines to individual practices.
This guideline addresses sealed sources as they are used for LDR brachytherapy. Guidelines for unsealed sources can be found in the National Guideline Clearinghouse (NGC) summary of the American College of Radiology (ACR) Practice Guideline for the Performance of Therapy with Unsealed Radiopharmaceutical Sources.
Process of Brachytherapy
The use of LDR brachytherapy is a complex process involving trained personnel who must work in concert to carry out a variety of interrelated activities. Communication among brachytherapy team members and well-defined procedures are essential for accurate and safe treatment.
- Clinical Evaluation
The initial evaluation of the patient includes history physical examination review of pertinent diagnostic studies and reports and communication with the referring physician and other physicians involved in the patient's care. The extent of the tumor must be determined and recorded for staging. This will facilitate treatment decisions determine the prognosis of the patient and enable a comparison of treatment results.
- Establishing Treatment Goals
LDR brachytherapy is indicated for treatment where the target volume can be well defined and is accessible to source placement. Brachytherapy is commonly used as adjunctive treatment to accompany external beam therapy increasing the total dose to a specified target volume.
The goal of treatment (curative palliative or to establish local tumor control) should be documented as clearly as possible. Treatment options and their relative merits and risks should be discussed with the patient. Integration of brachytherapy with external beam therapy should be defined. A summary of the consultation should be communicated to the referring physician.
- Informed Consent
Informed consent must be obtained and documented.
- Applicator/Source Insertion
Oncologic practice including brachytherapy commonly requires the interaction of multiple specialists. The choice and placement of after-loading applicators and loading and unloading of radioactive sources are the responsibility of the radiation oncologist.
Each type of brachytherapy procedure has its own set of unique characteristics. The brachytherapy team should operate according to an established system of procedural steps that have been developed by the radiation oncologist and brachytherapy team members. This systematic approach to applicator or source insertion should include a description of preimplantation steps sedation or anesthesia procedures the specific applicators used and the insertion techniques. Standard orders or care guidelines may enhance the systematic approach to the insertion process.
- Treatment Planning
LDR brachytherapy is administered according to the written signed and dated prescription of the radiation oncologist. Before loading the prescription must designate the treatment site the isotope the number of sources the planned dose and the dose rate to designated points. Applicator geometry and isotope positions are defined with simulation radiographs. The specific isotope positions are designated by the radiation oncologist as part of the LDR prescription. Computerized dosimetry is performed by the medical physicist or his/her designee and approved by the radiation oncologist. Independent verification of brachytherapy parameters (by another person or another method) is done pretreatment (see Patient and Personnel Safety section below).
- Treatment Delivery
LDR sources are manually or remotely loaded into applicators to deliver the prescribed treatment. If treatment modification is required such modification must be documented. Treatment delivery must be subject to detailed scrutiny as described in the Patient and Personnel Safety section (see below).
- Radiation Safety Considerations
Patients should be provided with written descriptions of the radiation protection guidelines including but not limited to discussion of potential limitations of patient contact with minors and pregnant women.
Safety considerations should be consistent with state and federal regulations. The radiation oncologist the medical physicist and the radiation safety officer should define the radiation safety guidelines.
- Patient Evaluation during Temporary Implants
The radiation oncologist evaluates patients on a regular basis during their brachytherapy treatment. Applicator and source placement medical condition and radiation safety issues should be addressed during the course of therapy. The patient's progress through therapy is documented in the hospital chart. At the end of treatment the patient and room must be surveyed to ensure that all radiation sources have been retrieved.
- Treatment Summary
At the conclusion of the course of treatment a written summary of the treatment delivery parameters should be generated including the total dose of brachytherapy and the total dose of external beam therapy if given treatment technique treatment volume acute side effects clinical course and patient disposition.
- Follow-Up Evaluation
Patients treated with brachytherapy should be evaluated after treatment at regular intervals by the radiation oncologist for response and early and late effects on normal tissues.
Qualifications of Personnel
The brachytherapy team includes the physician physicist dosimetrist radiation therapist nurse and radiation safety officer. Qualifications of the brachytherapy team include credentials listed below:
- Radiation Oncologist
Satisfactory completion of an Accreditation Council for Graduate Medical Education (ACGME) approved residency program in radiation oncology.
OR
Certification in Radiology by the American Board of Radiology of a physician who confines his/her professional practice to radiation oncology. Alternatively certification in Radiation Oncology or Therapeutic Radiology by the American Board of Radiology the American Osteopathic Board of Radiology the Royal College of Physicians and Surgeons of Canada or Le College des Medecins du Quebec may be considered proof of adequate physician qualifications.
- Qualified Medical Physicist
A Qualified Medical Physicist is an individual who is competent to practice independently in one or more of the subfields in medical physics. The American College of Radiology considers that certification and continuing education in the appropriate subfield(s) demonstrate that an individual is competent to practice one or more of the subfields in medical physics and to be a Qualified Medical Physicist. The ACR recommends that the individual be certified in the appropriate subfield(s) by the American Board of Radiology (ABR).
The appropriate subfields of medical physics for this guideline are Therapeutic Radiological Physics and Radiological Physics.
The continuing education of a Qualified Medical Physicist should be in accordance with the ACR Practice Guideline for Continuing Medical Education (CME).
- Radiation Therapist
Must fulfill state licensing requirements and should have American Registry of Radiologic Technologists (ARRT) certification in radiation therapy.
- Medical Dosimetrist
Certification by the Medical Dosimetrist Certification Board is recommended.
- Nurse
State licensure as a registered nurse or practical nurse is recommended
Equipment
LDR brachytherapy requires a variety of applicators to be used with manual or remote LDR applicators. After-loading LDR units applicators treatment-planning computers and software and procedure and treatment aids should be appropriately selected for the clinical applications. Regular inspection maintenance and repair of this equipment are mandatory. The physicist supervising the quality improvement program is responsible for documenting the maintenance and repair of manual equipment remote after-loading units and applicators. (See the ACR Technical Standard for the Performance of Brachytherapy Physics: Remotely Loaded HDR Sources.)
Patient and Personnel Safety
Patient protection measures include those related to medical safety and radiation protection.
- Patient protection measures should include:
- A radiation exposure-monitoring program as required by the Nuclear Regulatory Commission (NRC) or appropriate state agencies.
- Annual training of staff in emergency procedures in case of equipment malfunction.
- Charting systems and forms for prescription definition and delivery of treatment parameters and recording and summation of brachytherapy and external beam therapy treatment.
- A physics program for ensuring accurate dose delivery to the patient.
- A system for the radiation oncologist and physicist to verify independently (by another person or another method) all brachytherapy parameters to be used in each procedure (source isotope and activity dose rate total dose treatment duration etc.) prior to institution of LDR brachytherapy.
- Personnel safety measures should include:
- A radiation exposure-monitoring program as required by the Nuclear Regulatory Commission or appropriate state agencies.
- Routine leak testing of all sealed sources as required by regulatory agencies.
- Appropriate safety equipment for use of sealed sources.
Educational Program
Continuing medical education programs should include radiation oncologists medical physicists dosimetrists nurses and radiation therapy staff. Radiation safety programs should also include hospital-based personnel who will be involved with brachytherapy patients.
Educational programs initially and for retraining must cover the following:
- The safe operation of LDR applicators sources and manual or remote after-loading equipment as appropriate to the individual's responsibilities.
- Treatment techniques and new developments in radiation oncology and brachytherapy.
The program should be in accordance with the ACR Practice Guideline for Continuing Medical Education (CME).
Documentation
Reporting should be in accordance with the ACR Practice Guideline for Communication: Radiation Oncology.
Quality Control and Improvement Safety Infection Control and Patient Education Concerns
See the "Description of Implementation Strategy" field below.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is not specifically stated for each recommendation.
Potential Benefits
Appropriate performance of low-dose-rate brachytherapy to ensure accurate and safe treatment
Potential Harms
Side effects of radiation therapy
Qualifying Statements
- These guidelines are an educational tool designed to assist practitioners in providing appropriate radiologic care for patients. They are not inflexible rules or requirements of practice and are not intended nor should they be used to establish a legal standard of care. For these reasons and those set forth in the guideline the American College of Radiology cautions against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into question.
- The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in light of all the circumstances presented. Thus an approach that differs from the guidelines standing alone does not necessarily imply that the approach was below the standard of care.
- To the contrary a conscientious practitioner may responsibly adopt a course of action different from that set forth in the guidelines when in the reasonable judgment of the practitioner such course of action is indicated by the condition of the patient limitations on available resources or advances in knowledge or technology subsequent to publication of the guidelines. However a practitioner who employs an approach substantially different from these guidelines is advised to document in the patient record information sufficient to explain the approach taken.
- The practice of medicine involves not only the science but also the art of dealing with the prevention diagnosis alleviation and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore it should be recognized that adherence to these guidelines will not assure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge available resources and the needs of the patient to deliver effective and safe medical care. The sole purpose of these guidelines is to assist practitioners in achieving this objective.
Note: The licensing of radioactive sources and the safety of the general public and health care workers are regulated by the Nuclear Regulatory Commission (NRC) or by agreement states.* Medical use of isotopes for therapeutic procedures must adhere to the constraints set forth by these regulatory agencies. Detailed descriptions of NRC licensing and safety issues can be found in the Code of Federal Regulations Part 20 and Part 35. State requirements for the agreement states are found in the respective state statutes.
*An agreement state is any state with which the United States (US) Nuclear Regulatory Commission or the US Atomic Energy Commission has entered into an effective agreement under Subsection 274.b of the Atomic Energy Act of 964 as amended (73 Stat. 689).
Description of Implementation Strategy
Quality Control and Improvement Safety Infection Control and Patient Education Concerns
The Medical Director of Radiation Oncology is responsible for the institution and ongoing supervision of continuing quality improvement (CQI) as described in the National Guideline Clearinghouse (NGC) summary of the American College of Radiology (ACR) Practice Guideline for Radiation Oncology. It is the responsibility of the Director to identify problems see that actions are taken and evaluate the effectiveness of the actions. The Director will designate appropriate personnel to constitute the CQI Committee that will review low-dose-rate (LDR) brachytherapy as part of the CQI meeting agenda. Refer to the NGC summary of the ACR Practice Guideline for Radiation Oncology for a detailed description of CQI Committee functions.
Policies and procedures related to quality patient education infection control and safety should be developed and implemented in accordance with the ACR Policy on Quality Control Improvement Safety Infection Control and Patient Education Concerns appearing elsewhere in the ACR Practice Guidelines and Technical Standards book.
IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Safety
Bibliographic Source(s)
- American College of Radiology (ACR). ACR practice guideline for the performance of low-dose-rate brachytherapy. Reston (VA): American College of Radiology (ACR); 2005. 5 p. [19 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American College of Radiology
Guideline Committee
Guidelines and Standards Committee
Composition of Group that Authored the Guideline
Committee Members: Laurie E. Gaspar MD MBA Chair; E. Brian Butler MD; Nancy A. Ellerbroek MD; Beth A. Erickson MD; Cassandra S. Foens MD; Song K. Kang MD; Peter M. Mauch MD; Tariq A. Mian PhD; Seth A. Rosenthal MD; Anthony H. Russell MD; Oscar E. Streeter Jr. MD; Vipul V. Thakkar MD; Frank A. Vicini MD; Steven A. Leibel MD Chair Commission
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: American College of Radiology (ACR). ACR practice guideline for the performance of low-dose-rate brachytherapy. Reston (VA): American College of Radiology (ACR); 2000.
Guideline Availability
Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.
Print copies: Available from the American College of Radiology 1891 Preston White Drive Reston VA 20191. Telephone: (703) 648-8900.
Availability of Companion Documents
The following are available:
- ACR practice guidelines and technical standards purpose and intended use. Reston (VA): American College of Radiology; 1 p. Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.
- The process for developing ACR practice guidelines and technical standards. Reston (VA): American College of Radiology; 1 p. Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on May 18 2007. The information was verified by the guideline developer on May 29 2007.
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