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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer|
- Evaluate whether routine clinical use of intravenous zoledronic acid therapy affects technetium methylidene diphosphonate (Tc-99 MDP) uptake in bone metastases. [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582920
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ravinder Grewal, MD||Memorial Sloan Kettering Cancer Center.|