Molecular Imaging of Breast Cancer With Breast PET/CT

Study Overview
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Brief Summary
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This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.

Detailed Description
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PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.

Official Title
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Molecular Imaging of Breast Cancer With Breast PET/CT

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Positron emission tomography and computed tomography
* Radiation: Positron emission tomography and computed tomography
* Radiation: Positron emission tomography and computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Normal Adult Volunteers Female, at least 18 years of age Ability to lie motionless for up to 20 minutes Patient Volunteers Female, at least 18 years of age Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5) Not pregnant or breast-feeding Ability to lie motionless for up to 20 minutes Exclusion Criteria: Normal Adult Volunteers Inability to understand the risks and benefits of the study Patient Volunteers Recent breast biopsy Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma Uncontrolled diabetes Diabetic and blood sugar level > 200 mg/dL Positive urine pregnancy test or currently breast-feeding Inability to understand the risks and benefits of the 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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Other: 1<br>Normal volunteers | Radiation: Positron emission tomography and computed tomography<br>* Positron emission tomography and computed tomography<br>* Other names: Breast imaging;|
| Active Comparator: 2<br>Breast PET/CT scan | Radiation: Positron emission tomography and computed tomography<br>* Positron emission tomography and computed tomography<br>* Other names: Breast imaging;|
| Active Comparator: 3<br>Whole body and breast PET/CT | Radiation: Positron emission tomography and computed tomography<br>* Positron emission tomography and computed tomography<br>* Other names: Breast imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer