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Clinical Trials/NCT01222416
NCT01222416
Terminated
Not Applicable

Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer

Vanderbilt-Ingram Cancer Center1 site in 1 country50 target enrollmentOctober 2010
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Vanderbilt-Ingram Cancer Center
Enrollment
50
Locations
1
Primary Endpoint
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
April 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

A Bapsi Chakravarthy, MD

Associate Professor; Radiation Oncologist

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)

Time Frame: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)

The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the

Secondary Outcomes

  • Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.(48 months)

Study Sites (1)

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