[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Correlation Coefficient Between FFNP Uptake and Allred Score
研究概览
简要总结
The goal of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer. The hypothesis is that FFNP SUVmax from PET/MRI will correlate well against the semi-quantitative PR immunohistochemistry score.
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 test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer.
This is a prospective, one-arm, study which will enroll patients with newly diagnosed breast cancer scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Participation in this research study includes a directed breast PET/MRI with the investigational radiopharmaceutical, FFNP. FFNP uptake of the known, biopsy-proven malignancy will be measured on the PET/MRI examinations using standardized uptake values (SUV) and tumor-to-normal tissue ratios.
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
- •Women 18 years of age or older
- •Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
- •Biopsy-proven PR-positive or PR-negative invasive breast cancer
- •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
- •Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
- •Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
- •Participants with breast expanders
- •Participants who are or might be pregnant or lactating
- •Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
- •Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
- •Participants in liver failure as judged by the patient's physician
- •Participants with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI
- •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 subject 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
- •Participants unable to lie prone for 30 minutes for imaging
研究组 & 干预措施
FFNP PET/MRI
18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.
干预措施: [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging (Drug)
结局指标
主要结局
Correlation Coefficient Between FFNP Uptake and Allred Score
时间窗: Up to 1 day
To compare FFNP uptake of biopsy-proven primary PR+ breast malignancies measured using PET/MRI with the reference standard of PR immunohistochemistry (IHC) using a semi-quantitative score obtained by using the Allred score (0-8; the higher the score, the more receptors were found). The correlation of the two measures will be evaluated with Pearson's correlation coefficient. The null hypothesis is H0: p0=0.50 and the alternative hypothesis is H1: p1 =0.75.
次要结局
- Test-Retest Reproducibility(Up to 4 weeks)
- Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Optimal Cut Point(up to 4 weeks)
- Intra and Inter-Observer Assessment(Up to 4 weeks)
- Correlation Coefficient Between Tumor FFNP Uptake With Oncotype DX Score(Up to 4 weeks)
- Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Area Under the Curve (AUC)(up to 4 weeks)