PET/CT Evaluation of Treatment Response in Breast Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiopharmaceutical Administration [18F]-FDG
* Radiation: Radiopharmaceutical: [18F]-FLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must have histologically proven breast cancer Subjects are being considered for preoperative chemotherapy Subjects must be ≥ 18 years old. Sensor Sub-Study Only Palpable subcutaneous or known disease with one surface <1cm below surface of skin. A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing. Exclusion Criteria Children will be excluded from this study. Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology PET Procedure Screening Form will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential). Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study. Intraluminal lesions will be excluded from the sensor sub-study. Non biopsy proven malignancy will be excluded from this study. Palpable subcutaneous or known disease with one surface >1cm below surface of skin will be excluded from the sensor sub-study. Draining or exposed malignant tumor will be excluded from the sensor sub-study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluorodeoxyglucose PET/CT (FDG-PET/CT)<br>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. | Radiation: Radiopharmaceutical Administration [18F]-FDG<br>* Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.<br>|
| Experimental: fluorodeoxythymidine PET/CT (FLT-PET/CT)<br>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. | Radiation: Radiopharmaceutical: [18F]-FLT<br>* Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) | 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 | up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |