**7. Clinical indications**

Several indications for these technologies have been proposed in the medical literature. Generally speaking, BSGI/MBI has been examined as a diagnostic adjunct to mammography and ultrasound when these imaging modalities are inconclusive or discordant with other imaging studies and/or clinical signs and symptoms and there is a remaining diagnostic concern. In addition, there is good data to suggest that it is also useful in pre-operative treatment planning for patients with known malignancy and in monitoring the response of the breast lesion(s) to neoadjuvant chemotherapy, see section 5.1. The majority of studies on PEM have examined its use as in preoperative treatment planning for patients with know malignancy and in monitoring the response of breast tumor(s) to neoadjuvant chemotherapy.

In June of 2009, an interdisciplinary committee established by the American College of Surgeons published a report to provide guidance on the use of imaging techniques in breast patients (Silverstein et al., 2009). This panel grouped BSGI/MBI and PEM together as molecular imaging techniques and issued the following recommendation:


#### **7.1 Recognized BSGI/MBI indications**

192 Imaging of the Breast – Technical Aspects and Clinical Implication

The overall sensitivity and specificity for PEM is very good, especially for DCIS. Table 9 lists for each of the four PEM studies cited, the total number enrolled, the sensitivity, specificity,

> Total Patients 77 44 182 Sensitivity (%) 90 89 85 Specificity (%) 86 NR 74 NPV (%) 88 NR NR

In clinical studies of BSGI/MBI and PEM, both of these metabolic imaging modalities provide improved sensitivity and specificity for the diagnosis of breast cancer compared to mammography alone. The sensitivity and specificity of BSGI and PEM are generally comparable with both modalities demonstrating the capability to visualize lesions as small

Both BSGI and PEM provide valuable clinical information in the detection and treatment of breast carcinoma. Like all imaging studies, each has distinct advantages and limitations. From the clinical data, it is evident that the performance of these modalities is quite comparable.

The biggest differences between the procedures are logistical. First, in most areas, MIBI is more readily available and significantly less expensive than FDG. In addition, the shorter half-life of FDG puts tighter constraints on the clinical schedule. For example, if a patient arrives 1 hour late for a FDG injection, the dose has lost 32% of the intended activity where as a MIBI dose has lost 9%. Also, the use of FDG requires four hours of patient fasting prior to injection and MIBI does not have this constraint. FDG also requires a 1-hour post-injection delay for imaging where as MIBI imaging can begin immediately post injection. Based on the injection-to-imaging time considerations, total time required for a MIBI study is

Several indications for these technologies have been proposed in the medical literature. Generally speaking, BSGI/MBI has been examined as a diagnostic adjunct to mammography and ultrasound when these imaging modalities are inconclusive or discordant with other imaging studies and/or clinical signs and symptoms and there is a remaining diagnostic concern. In addition, there is good data to suggest that it is also useful in pre-operative treatment planning for patients with known malignancy and in monitoring the response of the breast lesion(s) to neoadjuvant chemotherapy, see section 5.1. The majority of studies on PEM have examined its use as in preoperative treatment planning for patients with know malignancy and in monitoring the response of breast tumor(s) to

as 1 – 2 mm. Both PEM and BSGI/MBI systems have biopsy guidance capabilities.

approximately 45 minutes compared to approximately 2 hours for an FDG study.

Table 9. Clinical results of PEM imaging. NR = not reported.

Berg, 2006 Tafra, 2005 Schilling, 2011

and negative predictive value.

**6. Clinical considerations** 

**7. Clinical indications** 

neoadjuvant chemotherapy.

In June 2009, the Society of Nuclear Medicine released the Procedural Guidelines for Breast Scintigraphy with Breast-Specific Gamma Cameras that included several proposed several indications for BSGI/MBI (Goldsmith et al., 2009). The indications are quite specific and echoed those set forth by the American College of Surgeons. The indications can be grouped into 4 primary categories.


#### **7.2 Recognized PEM indications**

There are no additional published guidelines for PEM other than those of the American College of Surgeons that essentially provided three indications:

