Starting a Treatment Program

Qualifications

In order for a hospital to become credentialed to treat patients with SIR-Spheres microspheres, several key elements must be in place. Most importantly, the hospital must have an existing cancer center or established GI medical oncology program with a team experienced in treating patients with colorectal metastases. The facility should have a hepatobiliary program with a surgical oncology and radiation oncology team on staff.

The hospital must have an interventional radiology department experienced in oncologic procedures. The interventional radiologists should participate regularly in multidisciplinary Tumor Board meetings and follow patients in their clinic.

The oncology program or cancer center should have extensive experience administering regional cancer therapies such as trans-arterial chemo-embolization (TACE), radio frequency ablation (RFA) and chemotherapy.

The hospital should identify an individual to serve in the capacity of clinical coordinator to oversee various aspects of treatment and scheduling.

Regulatory and safety considerations

The hospital ideally should have a full-time radiation safety officer (RSO) who ensures that the institution is properly licensed to receive and handle SIR-Spheres microspheres, and oversees safe use of the product. This includes dose preparation, microspheres administration and patient/staff safety.

Administration of the SIR-Spheres microspheres must be supervised by an authorized user as defined by regulatory requirements. In most instances, the authorized user is a radiation oncologist [see PDF Nuclear Regulatory Commission: Medical Use of Byproduct Material - Recognition of Specialty Boards; Final Rule ].

Radioactive materials licensing (RML)

In order to be credentialed, the hospital's RML must include yttrium-90 as an approved isotope, and if not already included, it will be necessary to have the hospital's RML amended to include SIR-Spheres microspheres yttrium-90 microspheres. Obtaining approval from the governing regulatory body can take anywhere from several weeks to several months.

Licensing guidance can be obtained from the Nuclear Regulatory Commission (NRC).

TEQ policy

To treat patients with SIR-Spheres microspheres on a regular basis, the hospital must complete the Sirtex Training/Education/Qualification (TEQ) policy. This policy sets standards governing training and education related to the administration of SIR-Spheres microspheres.