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Guideline Summary
Guideline Title
ACR–ASTRO practice guideline for the performance of low-dose-rate brachytherapy.
Bibliographic Source(s)
American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO). ACR-ASTRO practice guideline for the performance of low-dose-rate brachytherapy. [online publication]. Reston (VA): American College of Radiology (ACR); 2010. 6 p. [27 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)
  • Gynecologic malignancies
  • Head and neck malignancies
  • Sarcomas
  • Malignancies of the bronchus and trachea
  • Central nervous system malignancies
  • Gastrointestinal malignancies
  • Genitourinary malignancies
Guideline Category
Evaluation
Management
Treatment
Clinical Specialty
Internal Medicine
Nuclear Medicine
Oncology
Radiation Oncology
Radiology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Nurses
Physician Assistants
Physicians
Guideline Objective(s)
  • To assist practitioners in providing appropriate radiologic care for patient
  • To describe principles of practice for performance of low-dose-rate brachytherapy
Target Population

Patients undergoing low-dose-rate brachytherapy

Interventions and Practices Considered
  1. Clinical evaluation
  2. Establishing treatment goals
  3. Obtaining informed consent
  4. Choice and placement of afterloading applicators and loading and unloading of radioactive sources
  5. Treatment planning
  6. Treatment delivery
  7. Radiation safety considerations
  8. Patient evaluation during temporary implants
  9. Written treatment summary
  10. Follow-up evaluation
  11. Use of qualified personnel
  12. Appropriate patient selection
  13. Equipment specifications
  14. Ensuring patient and personnel safety
  15. Continuing education programs for staff on radiation safety
  16. Appropriate documentation
Major Outcomes Considered

Not stated

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The Medline literature search is based on keywords provided by the topic author. The two general classes of keywords are those related to the condition (e.g., ankle pain, fever) and those that describe the diagnostic or therapeutic intervention of interest (e.g., mammography, MRI).

The search terms and parameters are manipulated to produce the most relevant, current evidence to address the Practice Guideline or Technical Standard topic being reviewed or developed. Combining the clinical conditions and diagnostic modalities or therapeutic procedures narrows the search to be relevant to the topic. Exploding the term "diagnostic imaging" captures relevant results for diagnostic topics.

The following criteria/limits are used in the searches.

  1. Articles that have abstracts available and are concerned with humans.
  2. Restrict the search to the year prior to the last topic update or in some cases the author of the topic may specify which year range to use in the search. For new topics, the year range is restricted to the last 5 years unless the topic author provides other instructions.
  3. May restrict the search to Adults only or Pediatrics only.
  4. Articles consisting of only summaries or case reports are often excluded from final results.

The search strategy may be revised to improve the output as needed.

Number of Source Documents

The total number of source documents identified as the result of the literature search is not known.

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
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

Recommendations are formulated through iterative review by committee, collaborating societies, and membership. Suggested recommendations are reviewed by the committee and agreement is reached by consensus.

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
Internal Peer Review
Description of Method of Guideline Validation

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.

Recommendations

Major Recommendations

Brachytherapy is the use of radionuclides to treat malignancies or benign conditions by means of a radiation source placed close to or into the tumor or treatment site. This guideline refers only to the use of radionuclide brachytherapy. 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 for treating prostate, head and neck, breast, cervical, and endometrial cancers as well as obstructive esophageal or bronchial lesions. It has been practiced for over a century with a variety of sources including radium-226, cesium-137, and, more recently, iridium-192, iodine-125, and palladium-103. LDR brachytherapy can be given as interstitial, intracavitary, or intraluminal therapy to a wide variety of treatment sites.

LDR brachytherapy is accomplished by 1) temporary implants, i.e., afterloading radioactive sources into applicators that are placed into the patient, or 2) permanent implants, placing the radioactive sources permanently into the cancerous tissue. Source handling and loading into the applicator or tissue can be performed manually or remotely, 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. Brachytherapy can also be administered using remote afterloading, high-dose-rate (HDR) techniques. The use of HDR brachytherapy is covered in the "ACR–ASTRO Practice Guideline for the Performance of High-Dose-Rate Brachytherapy" (see the National Guideline Clearinghouse [NGC] summary).

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 "ACR–ASTRO Practice Guideline for the Performance of Therapy with Unsealed Radiopharmaceutical Sources" (see the NGC summary).

The use of LDR permanent brachytherapy for prostate cancer is covered in a separate "ACR–ASTRO Practice Guideline for Transperineal Permanent Brachytherapy of Prostate Cancer" (see the NGC summary).

There is a separate practice guideline referring to the practice of vascular brachytherapy. See the "ACR Practice Guideline for the Performance of Coronary Vascular Brachytherapy (CVBT)" (see the American College of Radiology [ACR] Web site for this practice guideline and additional ones mentioned below).

The licensing of radioactive sources (radionuclides) 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 radionuclides 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 U.S. Nuclear Regulatory Commission or the U.S. Atomic Energy Commission has entered into an effective agreement under Subsection 274.b of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

Process of Brachytherapy

The use of LDR brachytherapy is a complex multistep 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.

  1. 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. Staging facilitates treatment decisions, determines the prognosis of the patient, and enables a comparison of treatment results. Clinical evaluation and staging are discussed in the "ACR Practice Guideline for Radiation Oncology."

  2. Establishing Treatment Goals

    LDR brachytherapy is indicated for treatment when 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 or other therapies is necessary to define the intended course of treatment. A summary of the consultation should be communicated to the referring physician. See the "ACR Practice Guideline for Communication: Radiation Oncology."

  3. Informed Consent

    Informed consent must be obtained and documented as logistically feasible. See the "ACR Practice Guideline on Informed Consent – Radiation Oncology."

  4. Applicator/Source Insertion

    Oncologic practice, including brachytherapy, commonly requires the interaction of multiple specialists. The choice and placement of afterloading applicators and the 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 procedures, sedation or anesthesia needs, applicator options, and insertion techniques. Standard orders or care guidelines may enhance the systematic approach to the insertion process.

  5. Treatment Planning

    LDR brachytherapy is administered according to the written, signed, and dated prescription of the radiation oncologist. Before treatment, the final prescription must designate the treatment site, the radionuclide used, the number of sources, the planned total dose, and the dose rate at designated points. Applicator geometry and source positions are defined with localization images or cross-sectional imaging. The specific radionuclides 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 the Equipment section in the original guideline).

  6. 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 below.

  7. Radiation Safety Considerations

    Patients should be provided with written descriptions of the radiation protection guidelines, including, but not limited to, discussion of potential limitations on 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.

  8. 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.

  9. 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, any acute side effects, clinical course, and patient disposition.

  10. 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. See the "ACR Practice Guideline for Radiation Oncology."

Qualifications of Personnel

The brachytherapy team includes the physician, medical physicist, dosimetrist, radiation therapist, nurse, and radiation safety officer. See the original guideline for specific qualifications and credentials of the brachytherapy team.

Patient Selection Criteria

The use of brachytherapy is integral to the treatment of many malignancies, especially gynecologic, head and neck, sarcomas, bronchus and trachea, central nervous system (CNS), gastrointestinal and genitourinary malignancies. LDR prostate brachytherapy is discussed in the NGC summary of the ACR–ASTRO Practice Guideline for Transperineal Permanent Brachytherapy of Prostate Cancer. Temporary and permanent techniques can be used, depending on the clinical presentation as well as the experience, preference, and expertise of the treating physician.

In recent years, HDR brachytherapy has become more commonly used in many locales, and details of brachytherapy indications are included in the HDR practice guideline reference. LDR brachytherapy remains an appropriate method of dose delivery in clinical situations where brachytherapy is indicated.

Equipment

See the original guideline document for information about equipment specifications.

Patient and Personnel Safety

Patient protection measures include those related to medical safety and radiation protection.

  1. Patient Protection Measures Should Include:
    1. A radiation exposure-monitoring program, as required by the NRC or appropriate state agencies
    2. Annual (re)training of staff in emergency procedures in case of equipment malfunction, and brachytherapy-specific quality management procedures
    3. Charting systems and forms for dose specification, definition and delivery of treatment parameters, and recording and summation of brachytherapy and external beam therapy treatment
    4. A physics quality assurance program for ensuring accurate dose delivery to the patient
    5. A system for the radiation oncologist and medical physicist to verify independently (by another person or another method) pertinent brachytherapy parameters to be used in each procedure (e.g., source model, radionuclide, source strength, dose rate, total dose, and treatment duration) prior to LDR brachytherapy
  1. Personnel Safety Measures Should Include:
    1. A radiation exposure-monitoring program, as required by the NRC or appropriate state agencies
    2. Routine leak testing of all sealed sources, as required by regulatory agencies
    3. 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 used for both initial training and retraining must cover the following:

  1. The safe operation of LDR applicators, sources, and manual or remote afterloading equipment, as appropriate to the individual's responsibilities.
  2. 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." There should be documentation of parameters such as the actual number of sources, source strength(s), treatment duration (for temporary implants), and total dose after the implant has been completed.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate performance of low-dose-rate brachytherapy

Potential Harms

Side effects associated with low-dose-rate brachytherapy

Qualifying Statements

Qualifying Statements
  • These guidelines are an educational tool designed to assist practitioners in providing appropriate radiation oncology 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 below, 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 of 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.

Implementation of the Guideline

Description of Implementation Strategy

Quality Control and Improvement, Safety, Infection Control, and Patient Education

The Medical Director of Radiation Oncology is responsible for the institution and ongoing supervision of continuing quality improvement (CQI) as described in the "ACR Practice Guideline for Radiation Oncology" (see the American College of Radiology [ACR] Web site). 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 "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 and Improvement, Safety, Infection Control, and Patient Education appearing under the heading Position Statement on QC & Improvement, Safety, Infection Control, and Patient Education on the ACR Web site External Web Site Policy.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO). ACR-ASTRO practice guideline for the performance of low-dose-rate brachytherapy. [online publication]. Reston (VA): American College of Radiology (ACR); 2010. 6 p. [27 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
1996 (revised 2010)
Guideline Developer(s)
American College of Radiology - Medical Specialty Society
American Society for Radiation Oncology - Professional Association
Source(s) of Funding

American College of Radiology

Guideline Committee

Guidelines and Standards Committee of the Commission on Radiation Oncology in collaboration with the American Society for Radiation Oncology (ASTRO) and with the cooperation of the American Brachytherapy Society (ABS)

Composition of Group That Authored the Guideline

Collaborative Committee

American College of Radiology (ACR): Beth A. Erickson-Wittmann, MD, FACR (Chair); I-Chow Joe Hsu, MD; Geoffrey S. Ibbott, PhD, FACR; Seth A. Rosenthal, MD, FACR

American Society for Radiation Oncology (ASTRO): Daniel Fried, MD; John K. Hayes, MD, MS; Louis Potters, MD, FACR

American Brachytherapy Society (ABS): D. Jeffrey Demanes, MD, FACR

ACR Guidelines and Standards Committee for Radiation Oncology: Seth A. Rosenthal, MD, FACR (Chair); Nathan H.J. Bittner, MD; Beth A. Erickson-Wittmann, MD, FACR; Felix Y. Feng, MD; James M. Galvin, DSc; Brian J. Goldsmith, MD; Alan C. Hartford, MD, PhD; Maria D. Kelly, MB, BCh, FACR; Tariq A. Mian, PhD, FACR; Janelle L. Park, MD; Louis Potters, MD, FACR; Rachel A. Rabinovitch, MD; Michael A. Samuels, MD, FACR; Steven K. Seung, MD, PhD; Gregory M. Videtic, MD, CM; Maria T. Vlachaki, MD, PhD, MBA, FACR; Albert L. Blumberg, MD, FACR (Chair, Commission)

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site External Web Site Policy.

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:

  • The process of developing ACR practice guidelines and technical standards. Reston (VA): American College of Radiology. Electronic copies: Available from the American College of Radiology (ACR) Web site External Web Site Policy.
  • Purpose and intended use. Reston (VA): American College of Radiology. Electronic copies: Available from the ACR Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on December 5, 2011.

Copyright Statement

Copyright © by the American College of Radiology, 1891 Preston White Dr., Reston, VA 20191-4397, 703-648-8900. All rights reserved. No reproduction of this material in any format, electronic or otherwise, is permitted except with prior written consent from the American College of Radiology.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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