Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer

Osseous Lesions From Metastatic Breast Cancer Clinical Trial

Official title:

Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582920
• Other study ID #: 05-133
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2007
• Last updated: December 23, 2015
• Start date: January 2006
• Est. completion date: October 2008

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 110 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms
• Osseous Lesions From Metastatic Breast Cancer

Intervention

Radiation:
• Zometa™
Patients who will be receiving zoledronic acid therapy and are scheduled for an extent of disease evaluation with bone scan would undergo a second bone scan within 1 day of zoledronic acid therapy to assess changes in imaging.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate whether routine clinical use of intravenous zoledronic acid therapy affects technetium methylidene diphosphonate (Tc-99 MDP) uptake in bone metastases.		January 2009	No

External Links

•   Memorial Sloan-Kettering Cancer Center website