Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer
Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer
The purpose of this study is to examine for changes in the bone scan after treating with
 zoledronic acid (Zometa™). This study is designed to show if intravenous (IV)
 bisphosphonates, which are infused by vein, such as pamidronate (Aredia™) or zoledronic acid
 (Zometa™), cause changes in the result of bone scans in women with metastatic breast cancer.
 Both bone scans and the IV bisphosphonates are components of routine care of women with
 breast cancer that has spread to the bone.
Presently, intravenous bisphosphonates are routinely used every 3 to 4 weeks in patients with
 osseous metastases from breast cancer. However, there is no data addressing the effects of
 intravenous bisphosphonate therapy on the results of bone scan imaging. Therefore, the first
 step in the collaboration between MSKCC Breast Cancer Medicine Service and Nuclear Medicine
 Service is to define whether or not intravenous bisphosphonate therapy affects the results of
 bone imaging with the standard technetium, Tc-99m MDP. Women receiving intravenous
 bisphosphonate therapy for breast cancer metastases involving bone at MSKCC are eligible for
 this diagnostic clinical is no therapeutic intent in this study.

 Bone Scan performed before intravenous bisphosphonate therapy (baseline as clinically
 indicated). Ideally, the bone scan will be performed immediately before to, bisphosphonate
 therapy.

 Zoledronic acid, intravenous bisphosphonate therapy (as clinically indicated)

 Bone Scan performed within 1 day after intravenous bisphosphonate therapy (study test).

 Number of lesions seen in the baseline and study test will be counted and compared for
 changes in imaging results induced by intravenous bisphosphonate therapy.

 The number of lesions detected by bone scan pre and post therapy will be recorded and the
 difference will be calculated.
Inclusion Criteria:

 -  Patients receiving intravenous biphosphonate therapy (zoledronic acid 4 mg or renal
 dose equivalent) as part of their treatment regimen, who are diagnosed with metastatic
 breast cancer involving surrounding bone.

 -  Patients must have had prior treatment zoledronic acid (4 mg or adjusted dose for
 renal function) within 8 weeks.

 -  The patients clinical status as assessed by a treating physician must be deemed
 appropriate for continuing treatment with zoledronic acid

 -  The patient's clinical status, as assessed by a treating physician, must be deemed
 appropriate for an evaluation with a bone scan

 -  The patient's medical status as assessed by a treating physician must be medically
 appropriate to receive zoledronic acid within the study time frame and in association
 with the study bone scan

 Exclusion Criteria:

 -  No evidence of bone metastases, or less than 3 osseous lesions felt to be consistent
 with bone metastases, on most recent bone scan performed for clinical indications
 prior to study entry.

 -  Patients with illnesses, or conditions that would prevent them from understanding the
 nature of the study and complying with the protocol requirements