Positron Emission Tomography/Magnetic Resonance Imaging of Estrogen Receptor Expression n Non-Invasive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 18F-FES Uptake in DCIS
研究概览
简要总结
This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Eligible participants will be consented for participation in the research study which includes a directed breast PET/MRI with 18F-FES. 18F-FES uptake of the known malignancy will be measured on the PET/MRI examination using standardized uptake values (SUV) and tumor-to-normal tissue ratios.
详细描述
Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with Dynamic Contrast Enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to determine the technical feasibility of simultaneous breast DCE MRI with 18F-FES PET for measuring estrogen receptor (ER) in patients with ductal carcinoma in situ (DCIS) and identifying patients with low-risk of disease recurrence. The hypothesis is that quantitative 18F-FES uptake parameters from PET/MRI will correlate well with the ER immunohistochemistry score and with low-risk recurrence scores.
Primary Objective 1) To compare quantitative 18F-FES uptake of biopsy-proven DCIS measured using PET/MRI with ER protein levels determined by immunohistochemistry.
Secondary Objectives
- To determine the optimal cut-point 18F-FES uptake value for distinguishing between ER+ and ER-negative DCIS
- To determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES uptake
- To determine the optimal cut-point 18F-FES uptake value for distinguishing between low-risk DCIS and intermediate/high-risk DCIS
- To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with research-based Oncotype DX DCIS scores (0-100)
- To measure the upgrade rate to invasive cancer at surgical excision
- To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin levels.
Exploratory Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.0 cm in diameter by any imaging modality
- •Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
排除标准
- •Inability or unwillingness to provide informed consent to the study
- •Surgery, radiation, neoadjuvant chemo/endocrine therapy for the current malignancy prior to study enrollment
- •Participants currently taking or have taken an ER-blocking medication (e.g. tamoxifen, raloxifene) within 6 weeks prior to study enrollment
- •Pregnant or lactating women
- •Participant with intolerance or contraindications for MRI or gadolinium-based contrast agents
- •Participant girth exceeds the bore of the MRI/PET scanner
- •Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES
- •Participants in liver failure as judged by the patient's physician, due to the hepatobiliary clearance of 18F-FES
- •Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
- •The participant has their own prescription for the medication
- •The informed consent process is conducted prior to the self-administration of this medication
- •They come to the research visit with a driver or an alternative plan for transportation (e.g. Uber, taxi, etc.)
研究组 & 干预措施
Research Arm
Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination
干预措施: (18F)FES (Drug)
Research Arm
Directed breast PET/MRI with 18F-FES; 18F-FES uptake of the known malignancy to be measured on the PET/MRI examination
干预措施: Gadobenate dimeglumine (Drug)
结局指标
主要结局
18F-FES Uptake in DCIS
时间窗: 1 day
18F-FES uptake of biopsy-proven ductal carcinoma in situ (DCIS) measured using PET/MRI will be reported in Standardized Uptake Values (SUV).
次要结局
- Serum Estradiol Levels(1 day)
- Prognostic Risk Categories Determined Using Van Nuys Prognostic Index, the MSKCC Nomogram(2 months)
- Research-based Oncotype DX DCIS Scores(12 months)
- Number of Participants With Invasive Cancer at Surgical Excision(2 months)
- Serum Sex Hormone Binding Globulin Levels(1 day)