This is the current release of the guideline.

Adult and pediatric patients undergoing high-dose-rate brachytherapy

Not stated

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.

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

Not applicable

Not stated

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.

Not applicable

A formal cost analysis was not performed and published cost analyses were not reviewed.

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.

Brachytherapy is the use of radionuclides or X-ray sources (electronic brachytherapy) 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 radionuclides for brachytherapy. Brachytherapy alone or combined with external beam therapy plays an important role in the management and treatment of patients with cancer. Such treatment can be given as interstitial, intracavitary, or intraluminal therapy. High-dose-rate (HDR) brachytherapy uses radionuclides such as iridium-192 at dose rates of 20 or more cGy per minute to a designated target point or volume. HDR brachytherapy is indicated for treating tumors or lesions where the treatment volume or targeted points are defined and accessible.

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 use of brachytherapy requires detailed attention to personnel, equipment, patient and personnel safety, and continuing staff education.

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 and regulations.

*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 HDR 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. See the "ACR Practice Guideline for Radiation Oncology" and the "ACR Practice Guideline for Communication: Radiation Oncology."

2. Establishing Treatment Goals

   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 evaluation should be communicated to the referring physician.

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 Insertion

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

5. Image Acquisition

   In most, but not all, applications images should be obtained of the implanted regions. In certain instances, clinical assessments without images may suffice for verifying applicator position. These images may be either film based (2-dimensional [2D]) or scan based 3-dimensional [3D]). The authorized user should select the optimal imaging studies for treatment planning. The purpose of these images is to acquire special images of the implant applicator, the treatment target, and, insofar as possible, the surrounding normal tissue. It is desirable to have 3D spatial information so that the relationship of the target and surrounding critical organs can be displayed and that the relationship of the applied dose to the target and to the normal critical structures can be determined. To help minimize imaging artifacts and localization uncertainties, computed tomography (CT) or magnetic resonance imaging (MRI) slice thicknesses on the order of 1 mm should be used.

6. Treatment Planning

   HDR 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 source positions, the planned total dose, the dose per fraction, and the total number of fractions. Applicator geometry and source dwell positions are defined with localization images or CT scans. Organ at risk points or volumes should be defined (i.e., urinary bladder catheter balloon, rectal catheter or contrast, fiducial marker or retractor, or vaginal packing). Computerized dosimetry is performed by the medical physicist or his or her designee and approved by the radiation oncologist before the treatment is delivered. Optimization techniques to shape the dose distribution are widely available but should be used carefully to avoid areas of over or under-dosages. An independent check of the dosimetry plan should be performed prior to treatment delivery (see section V of the original guideline).

7. Treatment Delivery

   Prior to each treatment, the medical physicist or radiation oncologist should verify the proper connection of each applicator to the planned delivery channel. The medical physicist should verify all treatment parameters at the HDR console prior to treatment, including the correspondence between planned source strength and afterloader source strength with appropriate corrections for decay and source changes. In a multifraction treatment regimen using indwelling needles or catheters, where interfraction movement is possible, a means of verifying accurate positioning of the applicators before subsequent fractions are delivered is important for accurate treatment delivery, optimal tumor control, and patient safety.

   HDR treatment is delivered by remote afterloading of high-activity radioactive sources or miniature X-ray tubes. Radiation safety considerations are essential for HDR procedures. The radiation oncologist and the medical physicist must be in the immediate vicinity at all times while HDR brachytherapy is being administered, and the patient and the functioning of equipment must be continuously monitored by video or audio means and/or direct observation. Treatment delivery must be subject to detailed scrutiny as described in the patient and personnel safety section (see below). At the end of each treatment, the patient and the room must be surveyed to ensure that the source has been retracted into the afterloading device.

8. 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. See the "ACR Practice Guideline for Communication: Radiation Oncology."

9. Follow-up Evaluation

   Patients treated with HDR brachytherapy should be evaluated at regular intervals for response and early and late effects on normal tissues.

Qualifications of Personnel

The HDR brachytherapy team includes the physician(s), medical physicist, dosimetrist, radiation therapist, nurse, and radiation safety officer. HDR brachytherapy requires extensive interaction between all members of the team. Because treatment is given with such a highly active source over a short duration, the consequences of error and possible misadministration are potentially serious with HDR brachytherapy. Communication among team members and well-defined procedures for performing HDR brachytherapy are essential for accurate and safe treatment. See the original guideline for specific qualifications and credentials of the brachytherapy team.

Patient Selection Criteria

1. Cervical Cancer

   Brachytherapy is essential in the definitive treatment of cervical cancer. This is combined with external beam irradiation and often chemotherapy. International randomized trials have concluded that HDR brachytherapy is equivalent to low-dose-rate (LDR) brachytherapy for local control, survival, and toxicity. Treatment planning is an integral part of cervical cancer brachytherapy due to the close proximity of the normal pelvic organs and the need for significant doses to be delivered to the cervix and paracervical tissues to achieve cure. Brachytherapy is used postoperatively in some patients following hysterectomy.

2. Endometrial Cancer

   Vaginal brachytherapy, with or without external beam, is frequently used following surgical staging in the treatment of patients with early endometrial carcinoma. Vaginal brachytherapy is an effective means of reducing the risk of a vaginal recurrence with a very low risk of morbidity. Brachytherapy is also used for patients with recurrent endometrial carcinoma, and in this setting is sometimes interstitial rather than intracavitary. Definitive irradiation requiring brachytherapy is used infrequently for patients with medically inoperable endometrial carcinoma.

3. Vaginal Cancer

   Brachytherapy is used alone or in combination with external beam irradiation in the curative treatment of cancers of the vagina. Depending on the bulk of residual disease following external beam irradiation, brachytherapy may be either intracavitary or interstitial.

4. Bile Duct

   Following surgery with radiation may be helpful in patients with positive margins or positive nodes. Brachytherapy can be used as a boost following external beam to areas of close or positive margin. External beam irradiation plus brachytherapy can be effective palliation for patients with unresectable disease. There is confirming data that radiation can provide long term local control and that dose escalation with brachytherapy may be important in better outcomes. Intraluminal brachytherapy alone can be used to palliate biliary obstruction along with percutaneous drainage.

5. Esophagus

   HDR brachytherapy has been used in the treatment of esophageal cancer, in the palliation of advanced disease, and in the definitive treatment of superficial cancer. HDR brachytherapy has also been used as a boost treatment following external beam radiation therapy (or combined external beam radiation therapy and chemotherapy). The improvement in local control must be balanced by the potential morbidities, with respect to esophageal HDR brachytherapy.

6. Bronchus/Trachea

   HDR brachytherapy has been used in treating malignancies involving the lung, bronchus, and trachea. In some cases it can be used in conjunction with external beam radiotherapy in definitive cases, and in the definitive treatment of primary tracheal carcinomas. More commonly, HDR brachytherapy has a well-established role in the palliation of primary and recurrent endobronchial lesions.

7. Prostate

   HDR brachytherapy may be used in combination with external beam radiation therapy in the treatment of prostate cancer in any risk group. It may also be administered as the sole treatment for low risk and some intermediate risk patients. There is a separate "ACR-ASTRO Practice Guideline for Transperineal Permanent Brachytherapy of Prostate Cancer" (see the National Guideline Clearinghouse [NGC] summary).

8. Breast

   HDR brachytherapy can be used as a lumpectomy bed boost, but is more commonly used as a technique for administering accelerated partial breast irradiation (APBI) as the sole radiation treatment following breast conserving surgery. This approach treats a limited volume of tissue around the lumpectomy cavity over a shortened time period (typically 10 treatments delivered twice daily over 5 treatment days). Techniques include multicatheter interstitial implants (placed free-hand or with utilization of templates) and intracavitary devices (balloon catheters and other similar devices). APBI is appropriate for selected patients with early breast cancer. Further information related to patient selection and indications is available from ASTRO and ACR documents.

9. Head and Neck

   LDR brachytherapy has long played an important role in the treatment of head and neck malignancies. The same operative techniques may be used for HDR brachytherapy. Tumors in the head and neck affect important structures; therefore, careful attention to dose principles that preserve tissue function are needed, particularly, multifraction regimens that avoid large doses per fraction. Computer-based dose optimization, advances in radiation safety, and improved nursing care are important reasons why LDR brachytherapy is being supplanted by HDR brachytherapy. Interstitial, intracavitary, surface applications (plesiotherapy), and intraoperative techniques are all used in head and neck HDR brachytherapy. Depending on the clinical circumstances, it may be applied as a single modality or as a boost treatment in combination with external beam radiation therapy. HDR brachytherapy may be used in many sites in the head and neck, particularly in the lip and oral cavity, the oropharynx, and the nasopharynx, and in the treatment of cancers of various histologies. It may also be used for re-irradiation in the event of tumor recurrence after external beam radiation therapy.

10. Soft Tissue Sarcoma

    HDR brachytherapy has a role in the treatment of soft tissue sarcoma because of the high doses of radiation which are required to obtain tumor control. It plays an important role in the multidisciplinary management of soft tissue sarcoma. It can be a part of definitive therapy, postoperative adjuvant therapy, intraoperative radiotherapy, and palliative treatment.

11. Pediatric Tumors

    In selected cases, HDR brachytherapy can be useful in managing pediatric tumors.

12. Skin

    Although skin cancer can be treated using a variety of radiotherapy techniques, HDR brachytherapy offers unique dosimetric properties that may be useful for treating skin cancer over irregularly shaped and difficult to access skin surfaces. Both interstitial and plesiotherapy (surface applicators) techniques can be used. HDR brachytherapy can be used in combination with surgery for keloids.

13. Intraoperative Brachytherapy

    HDR brachytherapy can be used intraoperatively for delivering a single high dose of radiation after maximal tumor resection and while the "tumor bed" is accessible and normal tissues can be displaced or shielded from the site of treatment. Special intraoperative applicators have been developed which conform to a wide variety of size and shape of tumor bed and which can be inserted with flexibility and precision. A shielded operating room is required for intraoperative HDR brachytherapy. In the absence of a shielded operating room, intraoperatively placed catheters may be used for postoperative fractionated HDR brachytherapy delivered in a shielded treatment room. These techniques may be used in a variety of tumor types and body sites.

14. Anorectal

    Interstitial, intraluminal, or intraoperative HDR brachytherapy may be used in the treatment of anal and rectal cancers. This modality can be part of a preoperative approach for resectable or locally advanced rectal cancers or for unresectable, inoperable, and recurrent disease. For anal cancers, HDR brachytherapy can be used as a boost after external beam radiotherapy, or as definitive treatment in carefully selected cases.

15. Other Indications

    The list of indications above is not meant to be comprehensive. The individual radiation oncologist may find HDR brachytherapy beneficial in a variety of other tumor types and specific clinical situations (e.g., penis, bladder, urethra, central nervous system, ocular).

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 in brachytherapy-specific quality management procedures
   3. Charting systems for dose specification, definition and delivery of treatment parameters, and recording and summation of HDR 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) all brachytherapy parameters to be used in each procedure (source model, radionuclide source strength (activity), total dose, treatment duration, etc.) prior to HDR brachytherapy treatment delivery
   6. Routine leak testing of all sealed sources as required by regulatory agencies
   7. Use of a hand-held radiation survey meter when initially entering the room after a source run

2. 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. Use of a hand-held radiation survey meter when initially entering the room after a source run
   4. 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, including emergency procedures, of HDR applicators and HDR remote afterloading equipment and sources 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."

None provided

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

Appropriate performance of high-dose-rate brachytherapy

Side effects associated with high-dose-rate brachytherapy

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 high-dose-rate (HDR) 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 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 .

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

American College of Radiology

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)

Collaborative Committee

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

American Society for Radiation Oncology (ASTRO): John K. Hayes, MD, MS; David Morris, MD; D. Jonathan Tward, MD, PhD

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; Steven K. Seung, MD, PhD; Gregory M. Videtic, MD, CM; Maria T. Vlachaki, MD, PhD, MBA, FACR; Albert L. Blumberg, MD, FACR (Chair, Commission)

Not stated

This is the current release of the guideline.

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.

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 .
• Purpose and intended use. Reston (VA): American College of Radiology. Electronic copies: Available from the ACR Web site .

None available

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

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.