PET/CT Evaluation of Treatment Response in Breast Cancer

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Radiation: Radiopharmaceutical Administration [18F]-FDG

• Registration Number: NCT01222416
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-29
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-18
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-03-21
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Results First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluorodeoxyglucose PET/CT (FDG-PET/CT)	Radiopharmaceutical Administration [18F]-FDG	A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.

Primary Outcome Measures

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

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States